Nasdaq Nordic · interim-report
Kvartalsrapport Q3 2023
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Omsättning
- Strong momentum in the year to date leads to increased guidance for Total Revenue ex COVID-19 medicines | and Core EPS
- Revenue and EPS summary
- $m Actual CER 1 $m Actual CER | - Product Sales 32,466 1 4 11,018 4 5 | - Alliance Revenue 2 1,004 99 99 377 76 75
- - Product Sales 32,466 1 4 11,018 4 5 | - Alliance Revenue 2 1,004 99 99 377 76 75 | - Collaboration Revenue 317 (28) (28) 97 (46) (47)
- - Alliance Revenue 2 1,004 99 99 377 76 75 | - Collaboration Revenue 317 (28) (28) 97 (46) (47) | Total Revenue 33,787 2 5 11,492 5 6
- - Collaboration Revenue 317 (28) (28) 97 (46) (47) | Total Revenue 33,787 2 5 11,492 5 6 | Total Revenue ex COVID-19 33,453 12 15 11,492 12 13
- Total Revenue 33,787 2 5 11,492 5 6 | Total Revenue ex COVID-19 33,453 12 15 11,492 12 13 | Reported 3 EPS 4 $3.22 >2x >2x $0.89 (16) (6)
- ‒ Total Revenue $33,787m, up 5% despite a decline of $2,896m from COVID-19 medicines 6
EBITDA
- Core financial measures, EBITDA, Net debt, Product Sales Gross Margin (formerly termed as Gross Margin ), | Operating Margin and CER are non-GAAP financial measures because they cannot be derived directly from the
- EBITDA is defined as Reported Profit before tax aft er adding back Net finance expense, results from Jo int | ventures and associates and charges for Depreciation, amortisation and impairment. Reference should be made
- ventures and associates and charges for Depreciation, amortisation and impairment. Reference should be made | to the Reconciliation of Reported Profit before tax to EBITDA included in the financial performance se ction in | this announcement.
- Table 12: Reconciliation of Reported Profit before tax to EBITDA
- 4,060 4,000 2 3 1,282 1,334 (4) (4) | EBITDA 11,019 6,663 65 77 3, 236 2,579 25 32
- EBITDA for the comparative 9M 2022 was negatively impacted by $3,175m unwind of inventory fair value uplift | recognised on the acquisition of Alexion. EBITDA fo r the comparative Q3 2022 was negatively impacted b y
- EBITDA for the comparative 9M 2022 was negatively impacted by $3,175m unwind of inventory fair value uplift | recognised on the acquisition of Alexion. EBITDA fo r the comparative Q3 2022 was negatively impacted b y | $857m unwind of inventory fair value uplift recogni sed on the acquisition of Alexion. This unwind had a $78m
Rörelseresultat
- gain from an update to the contractual relationship s for Beyfortus , totalling $712m and recorded in Core | Other operating income
- 22 Income from disposals of assets and businesses, where the Group does not retain a significant ongoing economic interest, continue to | be recorded in Other operating income and expense in the Company’s financial statements.
- ∗ See Product Sales Gross Margin, | expenses and Other operating income and | expense commentary above
- Operating Margin is defined as Operating profit as a percentage of Total Revenue.
- % Total Revenue 3.6% 1.0% +3pp +3pp 0.6% 1.0% - - | Operating profit 6,959 2,663 >2x >2x 1,954 1,245 57 69 | Operating Margin 20.6% 8.0% +13pp +14pp 17.0% 11.3% +6pp +7pp
- 55 Other Operating Income.
- 1,233 (61) - - - 1,172 >3x >3x | Operating profit 6,959 352 3,273 94 1,104 11,782 10 16 | Operating Margin 20.6% 34.9% +2pp +3pp
- 70 - - - - 70 (35) (34) | Operating profit 1,954 124 1,014 30 423 3,545 4 9 | Operating Margin 17.0% 30.8% - +1pp
Periodens resultat
- Taxation (1,000) 668 | Profit for the period 5,002 2,391 | Other comprehensive income
- Taxation (274) 720 | Profit for the period 1,378 1,642 | Other comprehensive income
- At 1 Jan 2022 387 35,126 2,045 1,710 39,268 19 39,287 | Profit for the period - - - 2,387 2,387 4 2,391 | Other comprehensive loss - - - (1,686) (1,686) (3) (1,689)
- At 1 Jan 2023 387 35,155 2,069 (574) 37,037 21 37,058 | Profit for the period - - - 4,995 4,995 7 5,002 | Other comprehensive loss - - - (88) (88) - (88)
Resultat per aktie
- Strong momentum in the year to date leads to increased guidance for Total Revenue ex COVID-19 medicines | and Core EPS
- Revenue and EPS summary
- Total Revenue ex COVID-19 33,453 12 15 11,492 12 13 | Reported 3 EPS 4 $3.22 >2x >2x $0.89 (16) (6) | Core 5 EPS $5.80 10 17 $1.73 4 9
- Reported 3 EPS 4 $3.22 >2x >2x $0.89 (16) (6) | Core 5 EPS $5.80 10 17 $1.73 4 9
- ‒ Core EPS increased 17% to $5.80
- ‒ FY 2023 Core EPS now expected to increase by a low double-digit to low-teens percentage at CER
- Accounting Standards as adopted by the European Union. | 4 Earnings per share. | 5 Core financial measures are adjusted to exclude certain items. The differences between Reported and Core measures are primarily due
- to costs relating to the acquisition of Alexion, amortisation of intangibles, impairments, legal settlements and restructuring charges. A full | reconciliation between Reported EPS and Core EPS is provided in Table 13 and Table 14 in the Financial performance section of this | document.
Kassaflöde
- Table 15: Cash Flow summary
- $190m, including a cash receipt from Sobi in Q1 202 3 after achievement of a regulatory milestone. The | associated cash flow is presented within investing activities.
- Foreign exchange arising on designated liabilities in net investment hedges (63) (321) | Fair value movements on cash flow hedges 62 (214) | Fair value movements on cash flow hedges transferred to profit and loss 28 250
- Fair value movements on cash flow hedges 62 (214) | Fair value movements on cash flow hedges transferred to profit and loss 28 250 | Fair value movements on derivatives designated in net investment hedges 47 33
- Foreign exchange arising on designated liabilities in net investment hedges 38 (126) | Fair value movements on cash flow hedges (27) (76) | Fair value movements on cash flow hedges transferred to profit and loss 99 119
- Fair value movements on cash flow hedges (27) (76) | Fair value movements on cash flow hedges transferred to profit and loss 99 119 | Fair value movements on derivatives designated in net investment hedges 7 (1)
- and net assets acquired of $1,268m, which included intangible assets acquired of $780m, $424m of cash and | cash equivalents, and $75m of marketable securities . The Condensed consolidated statement of cash flow s | includes a $1,204m payment for the intangible asset s which is presented net of the $424m cash and cash
- The table below provides an analysis of Net Debt and a reconciliation of Net Cash Flow to the movement in Net | Debt. The Group monitors Net Debt as part of its ca pital-management policy as described in Note 28 of the
Likvida medel
- $m $m $m | Cash and cash equivalents 4,871 6,166 4,458 | Other investments 244 239 440
- Income tax receivable 697 731 725 | Cash and cash equivalents 4,871 6,166 4,458 | Assets held for sale - 150 -
- Net cash outflow from financing activities (6,276) (6,465) | Net decrease in Cash and cash equivalents in the period (1,298) (1,766) | Cash and cash equivalents at the beginning of the period 5,983 6,038
- Net decrease in Cash and cash equivalents in the period (1,298) (1,766) | Cash and cash equivalents at the beginning of the period 5,983 6,038 | Exchange rate effects (66) (86)
- Exchange rate effects (66) (86) | Cash and cash equivalents at the end of the period 4,619 4,186
- 36 | Cash and cash equivalents consist of: | Cash and cash equivalents 4,871 4,458
- Cash and cash equivalents consist of: | Cash and cash equivalents 4,871 4,458 | Overdrafts (252) (272)
- Net borrowings (29,328) 883 (8) (81) 48 (28,486) | Cash and cash equivalents 6,166 (1,229) - - (66) 4,871 | Other investments - current 239 12 - - (7) 244
Nettoskuld
- Core financial measures, EBITDA, Net debt, Product Sales Gross Margin (formerly termed as Gross Margin ), | Operating Margin and CER are non-GAAP financial measures because they cannot be derived directly from the
- Net debt is defined as Interest-bearing loans and b orrowings and Lease liabilities, net of Cash and ca sh | equivalents, Other investments, and Net derivative financial instruments. Reference should be made to Note 3
- equivalents, Other investments, and Net derivative financial instruments. Reference should be made to Note 3 | ‘Net debt' included in the Notes to the Interim financial statements in this announcement.
- Taxation paid (1,710) (1,335) (375) | Net cash inflow from operating activities 7,965 7,410 555 | Net cash inflow before financing activities 4,978 4,699 279
- Net cash inflow from operating activities 7,965 7,410 555 | Net cash inflow before financing activities 4,978 4,699 279 | Net cash outflow from financing activities (6,276 ) (6,465 ) 189
- Net cash inflow before financing activities 4,978 4,699 279 | Net cash outflow from financing activities (6,276 ) (6,465 ) 189
- corresponding item (positive impact of $3,175m) in Decrease in working capital and short-term provisio ns. | Overall, the unwind of the fair value uplift had no impact on Net cash inflow from operating activities. This unwind | had $78m negative impact on 9M 2023 Reported Operat ing profit and offsetting positive impact on Workin g
- (nirsevimab) in the US, a gain of $712m has been re corded in non-cash and other movements, with no ove rall | net impact on the Net cash inflow from operating activities.
Bruttomarginal
- ‒ Core Product Sales Gross Margin 9 of 82%, up two percentage points, reflecting the decline in sales of lower | margin COVID-19 medicines
- 8 Respiratory & Immunology. | 9 The calculation of Reported and Core Product Sale s Gross Margin (formerly termed as Gross Margin) ex cludes the impact of Alliance | Revenue and Collaboration Revenue.
- 21 for the profit share due to its partner | ∗ Variations in Product Sales Gross Margin | can be expected between periods due to
- +1pp CER | ∗ See Product Sales Gross Margin, | expenses and Other operating income and
- Core financial measures, EBITDA, Net debt, Product Sales Gross Margin (formerly termed as Gross Margin ), | Operating Margin and CER are non-GAAP financial measures because they cannot be derived directly from the
- Product Sales Gross Margin (formerly termed Gross Margin) is the percentage by which Product Sales exceeds | the Cost of Sales, calculated by dividing the diffe rence between the two by the sales figure. The calc ulation of
- the Cost of Sales, calculated by dividing the diffe rence between the two by the sales figure. The calc ulation of | Reported and Core Product Sales Gross Margin exclud es the impact of Alliance Revenue and Collaboration | Revenue and any associated costs, thereby reflecting the underlying performance of Product Sales.
- Gross profit 27,827 23,653 18 22 9,397 8,000 17 20 | Product Sales Gross Margin 81.6% 70.5% +11pp +12pp 81.0% 71.8% +9pp +10pp | Distribution expense (394) (380) 4 6 (129) (126) 2 2
Fulltext
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1
AstraZeneca
9 November 2023
9M and Q3 2023 results
Strong momentum in the year to date leads to increased guidance for Total Revenue ex COVID-19 medicines
and Core EPS
Revenue and EPS summary
9M 2023 Q3 2023
% Change % Change
$m Actual CER 1 $m Actual CER
- Product Sales 32,466 1 4 11,018 4 5
- Alliance Revenue 2 1,004 99 99 377 76 75
- Collaboration Revenue 317 (28) (28) 97 (46) (47)
Total Revenue 33,787 2 5 11,492 5 6
Total Revenue ex COVID-19 33,453 12 15 11,492 12 13
Reported 3 EPS 4 $3.22 >2x >2x $0.89 (16) (6)
Core 5 EPS $5.80 10 17 $1.73 4 9
Financial performance (9M 2023 figures unless otherwise stated, growth numbers at CER)
‒ Total Revenue $33,787m, up 5% despite a decline of $2,896m from COVID-19 medicines 6
‒ Excluding COVID-19 medicines, both Total Revenue and Product Sales increased 15%
‒ Total Revenue from Oncology medicines increased 20 %, CVRM 7 19%, R&I 8 9%, and Rare Disease 12%
‒ Core Product Sales Gross Margin 9 of 82%, up two percentage points, reflecting the decline in sales of lower
margin COVID-19 medicines
‒ Core Operating Margin of 35% increased by three pe rcentage points including the previously-announced
gain from an update to the contractual relationship s for Beyfortus , totalling $712m and recorded in Core
Other operating income
‒ Core EPS increased 17% to $5.80
‒ FY 2023 Total Revenue excluding COVID-19 medicines now expected to increase by a low-teens
percentage at CER
‒ FY 2023 Core EPS now expected to increase by a low double-digit to low-teens percentage at CER
Pascal Soriot, Chief Executive Officer, AstraZeneca, said:
"Our company continued its strong growth trajectory in the third quarter with Total Revenue from our
non ‑COVID-19 medicines up 13% compared to last year.
1 Constant exchange rates. The differences between Actual Change and CER Change are due to foreign exchange movements between
periods in 2023 vs. 2022. CER financial measures are not accounted for according to generally accepted accounting principles (GAAP)
because they remove the effects of currency movements from Reported results.
2 Effective 1 January 2023, the Group has updated t he presentation of Total Revenue. For further detai ls of the presentation of Alliance
Revenue and Collaboration Revenue, see the Basis of preparation and accounting policies section of the Notes to the Interim financial
statements section.
3 Reported financial measures are the financial results presented in accordance with UK-adopted International Accounting Standards and
International Financial Reporting Standards (IFRSs) as issued by the International Accounting Standards Board (IASB) and International
Accounting Standards as adopted by the European Union.
4 Earnings per share.
5 Core financial measures are adjusted to exclude certain items. The differences between Reported and Core measures are primarily due
to costs relating to the acquisition of Alexion, amortisation of intangibles, impairments, legal settlements and restructuring charges. A full
reconciliation between Reported EPS and Core EPS is provided in Table 13 and Table 14 in the Financial performance section of this
document.
6 The COVID-19 medicines are Vaxzevria , Evusheld , and AZD3152 – the COVID-19 antibody currently in development.
7 Cardiovascular, Renal and Metabolism.
8 Respiratory & Immunology.
9 The calculation of Reported and Core Product Sale s Gross Margin (formerly termed as Gross Margin) ex cludes the impact of Alliance
Revenue and Collaboration Revenue.
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2
We initiated several Phase III trials of high-poten tial molecules this quarter, including for volrusto mig, our
PD-1/CTLA-410 bispecific antibody. Our portfolio of bispecifics has the potential to replace the first-generation
checkpoint inhibitors across a range of cancers. We also initiated a fixed dose combination study of zibotentan
with Farxiga which has the potential to significantly improve outcomes for patients with kidney disease not well
controlled on current standard of care.
I am excited about the acceleration of our cardiometabolic and obesity pipeline with today’s licensing agreement
for ECC5004, a potential best-in-class, oral GLP-1R A 11 . This molecule could offer an important advance, a s
both a monotherapy and in combinations, for the est imated one billion people living with cardiometabol ic
diseases such as type-2 diabetes and obesity.
Given the momentum in the year to date we have increased our full-year guidance for Total Revenue excluding
COVID medicines as well as for Core EPS."
Key milestones achieved since the prior results announcement
‒ Key positive read-outs: datopotamab deruxtecan in metastatic HR 12 -positive breast cancer
(TROPION-Breast01); Imfinzi in liver cancer (EMERALD-1); Fasenra in EGPA 13 (MANDARA)
‒ Key regulatory approvals: EU approval for Enhertu in HER2 14 -mutant lung cancer (DESTINY-Lung02); China
approvals for Forxiga in heart failure regardless of ejection fraction (D ELIVER); Calquence in r/rCLL 15
(ASCEND); Soliris in NMOSD 16 . Japan approvals for Lynparza in prostate cancer (PROpel); Enhertu in
HER2-mutant lung cancer (DESTINY-Lung02)
‒ Other milestones: Tagrisso granted US Breakthrough Therapy Designation and US Priority Review in
combination with chemotherapy for treatment of pati ents with locally advanced or metastatic EGFR m17
NSCLC 18 (FLAURA2); Enhertu granted US Breakthrough Therapy Designations in HER2-positive colorectal
cancer (DESTINY-CRC01, DESTINY-CRC02) and multiple types of HER2-expressing tumours
(DESTINY-PanTumor02)
Guidance
The Company updates its Total Revenue and Core EPS guidance for FY 2023 at CER, based on the average
foreign exchange rates through 2022.
Total Revenue is expected to increase by a mid single-digit percentage
(previously low-to-mid single-digit).
Excluding COVID-19 medicines, Total Revenue is expected to increase by a low-teens percentage
(previously low double-digit) .
Core EPS is expected to increase by a low double-digit to low-teens percentage
(previously high single-digit to low double-digit) .
Other elements of the Income Statement are expected to be broadly in line with the indications issued in the
Company's H1 2023 results announcement.
The Company is unable to provide guidance on a Repo rted basis because it cannot reliably forecast mate rial
elements of the Reported results, including any fai r value adjustments arising on acquisition-related liabilities,
intangible asset impairment charges and legal settlement provisions. Please refer to the cautionary statements
section regarding forward-looking statements at the end of this announcement.
10 Programmed cell death protein 1/cytotoxic T-lymphocyte-associated protein 4.
11 Glucagon-like peptide 1 receptor agonist.
12 Hormone receptor.
13 Eosinophilic granulomatosis with polyangiitis.
14 Human epidermal growth factor receptor 2.
15 Relapsed or refractory chronic lymphocytic leukaemia.
16 Neuromyelitis optica spectrum disorder.
17 Epidermal growth factor receptor mutation.
18 Non-small cell lung cancer.
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3
Currency impact
If foreign exchange rates for October to December 2023 were to remain at the average rates seen in September
2023, it is anticipated that FY 2023 Total Revenue would incur a low single-digit adverse impact versu s the
performance at CER, and Core EPS would incur a mid single-digit adverse impact (previously a low-to-mi d
single-digit adverse impact).
The Company's foreign exchange rate sensitivity analysis is provided in Table 19.
Table 1: Key elements of Total Revenue performance in Q3 2023
% Change
Revenue type $m Actual CER
Product Sales 11,018 4 5 ∗ Double-digit growth at CER in Oncology, CVRM
and Rare Disease
Alliance Revenue 377 76 75 ∗ $266m for Enhertu (Q3 2022: $160m)
∗ $74m for Tezspire (Q3 2022: $26m)
Collaboration Revenue 97 (46) (47) ∗ $71m for Beyfortus regulatory milestone
Total Revenue 11,492 5 6 ∗ Excluding COVID-19 medicines , Q3 2023 Total
Revenue increased by 12% (13% at CER)
Therapy areas
$m Actual % CER %
Oncology
4,664 15 17 ∗ Strong performance across key medicines and
regions
∗ No milestones from Lynparza in the quarter (Q3
2022: $75m)
CVRM
2,687 14 16 ∗ Farxiga up 41% , Lokelma up 30% (31% at
CER), roxadustat up 31% (39% CER), Brilinta
declined 2% (1% at CER)
R&I
1,549 3 5 ∗ Fasenra up 10%, Breztri up 66% (69% CER).
Saphnelo and Tezspire also continue to grow
rapidly during their launch phase, partially offset
by a 12% decline (10% at CER) in Symbicort
following entry of a generic competitor in the US
during the quarter
V&I 19
312 (64) (65) ∗ $nil revenue from COVID-19 mAbs and
Vaxzevria in the quarter (Q3 2022: $536m and
$180m respectively)
∗ Beyfortus $138m, including $50m of Product
Sales from product supplied to Sanofi, $71m of
Collaboration Revenue for a regulatory
milestone and $17m of Alliance Revenue for
AstraZeneca's share of gross profit outside US
Rare Disease
1,974 13 14 ∗ Ultomiris up 50% (49% at CER), partially offset
by decline in Soliris of 13% (12% at CER)
∗ Strensiq up 20% (21% at CER) and Koselugo
up 81% reflecting strong patient demand
Other Medicines 306 (36) (32) ∗ Nexium generic competition in Japan
Total Revenue 11,492 5 6
Regions inc. COVID-19 $m Actual % CER %
US 4,859 5 4
Emerging Markets 2,964 4 12
- China 1,452 (6) 1
- Ex-China Emerging Markets 1,513 15 25
Europe 2,392 16 9
Established RoW 1,276 (10) (6)
19 Vaccines & Immune Therapies.
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4
Total Revenue inc . COVID-19 11,492 5 6 • Growth rates impacted by lower sales of
COVID-19 medicines (see table below)
Regions ex . COVID-19 $m Actual % CER %
US 4,859 12 12
Emerging Markets 2,964 8 16
- China 1,452 (6) 1
- Ex-China Emerging Markets 1,513 25 36
Europe 2,392 23 16
Established RoW 1,276 5 10
Total Revenue ex. COVID-19 11,492 12 13
Table 2: Key elements of financial performance in Q3 2023
Metric
Reported Reported
change
Core Core
change
Comments 20
Total
Revenue $11,492m
5% Actual
6% CER $11,492m 5% Actual
6% CER
∗ Excluding COVID-19 medicines, Q3 2023
Total Revenue increased by 12% (13% at
CER)
∗ See Table 1 and the Total Revenue section
of this document for further details
Product
Sales Gross
Margin
81%
+9pp Actual
+10pp CER 81% +1pp Actual
+1pp CER
+ Favourable mix of sales from Oncology and
Rare Disease medicines
+ No sales of COVID-19 medicines
‒ Increasing mix of products with profit-
sharing
arrangements, where AstraZeneca books
Product Sales and records an expense in
COGS
21 for the profit share due to its partner
∗ Variations in Product Sales Gross Margin
can be expected between periods due to
product seasonality, foreign exchange
fluctuations and other effects
R&D
expense $2,584m
5% Actual
4% CER $2,485m 5% Actual
5% CER
+ Increased investment in the pipeline
∗ Core R&D-to-Total Revenue ratio of 22%
(Q3 2022: 21%)
∗ Year-on- year comparisons can be impacted
by differences in cost phasing driven by
study starts and execution
SG&A
expense $4,800m
12% Actual
12% CER $3,355m 6% Actual
7% CER
+ Market development for recent launches and
pre-launch activities
+ Reported SG&A impacted by increased
charges for legal provisions, including a
$425m charge to provisions relating to a
legal settlement in Q3 2023 (see Note 6)
∗
Core SG&A-to-Total Revenue ratio of 29%
(Q3 2022: 29%)
∗ Year-on-year comparisons can be impacted
by differences in cost phasing
Other
operating
income (and
expense)
22
$70m -34% Actual
-33% CER $70m -35% Actual
-34% CER
‒ Discontinuation of brazikumab development
20 In Table 2, the plus and minus symbols denote the directional impact of the item being discussed, e. g. a ‘+’ symbol next to an R&D
expense comment indicates that the item increased the R&D expense relative to the prior year.
21 Cost of goods sold.
22 Income from disposals of assets and businesses, where the Group does not retain a significant ongoing economic interest, continue to
be recorded in Other operating income and expense in the Company’s financial statements.
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5
Operating
Margin 17%
+6pp Actual
+7pp CER 31% Stable at Actual
+1pp CER
∗ See Product Sales Gross Margin,
expenses and Other operating income and
expense commentary above
Net finance
expense $291m -
9% Actual
-6% CER $223m -12% Actual
-7% CER
+ Higher interest received on cash and short-
term investments, broadly offset by higher
rates on floating debt and bond issuances
Tax rate 17% n/m Actual
n/m CER 19% +1pp Actual
+1pp CER
∗ Variations in the tax rate can be expected
between periods
EPS $0.89 -16% Actual
-6% CER $1.73 4% Actual
9% CER
∗ Further details of differences between
Reported and Core are shown in Table 14
Table 3: Pipeline highlights since prior results announcement
Event Medicine Indication / Trial Event
Regulatory
approvals and
other
regulatory
actions
Lynparza mCRPC
23 (1st-line) (PROpel) Regulatory approval (JP)
Enhertu HER2m 24 NSCLC (2nd-line+)
(DESTINY-Lung02)
Positive CHMP Opinion (EU),
Regulatory approval (EU, JP)
Calquence CLL
25 (ASCEND) Regulatory approval (CN)
Forxiga HFpEF 26 (DELIVER) Regulatory approval (CN)
Soliris NMOSD Regulatory approval (CN)
Regulatory
submissions
or
acceptances*
Tagrisso EGFR m NSCLC (1st-line)
(FLAURA2)
Regulatory submission (US, EU,
CN), Priority Review (US)
Imfinzi NSCLC (neoadjuvant) (AEGEAN) Regulatory submission (US)
capivasertib HR+/HER2-negative breast cancer
(2nd-line) (CAPItello-291)
Regulatory submission (CN)
roxadustat Chemotherapy-induced anaemia Regulatory submission (CN)
FluMist Self-administered influenza vaccine Regulatory submission (US)
Major Phase
III data
readouts and
other
developments
Imfinzi Liver cancer (locoregional)
(EMERALD-1) Primary endpoint met
datopotamab
deruxtecan
HR+/HER2-breast cancer
(inoperable and/or metastatic)
(TROPION-Breast01)
Primary endpoint met
Fasenra EGPA (MANDARA) Primary endpoint met
*US, EU and China regulatory submission denotes filing acceptance
Upcoming pipeline catalysts
For a table of anticipated timings of key trial rea douts, please refer to page 2 of the Clinical Trial s Appendix,
available on www.astrazeneca.com/investor-relations.html .
Other pipeline updates
Ultomiris discontinued plans to deliver subcutaneous adminis tration for adults with aHUS 27 or PNH 28 . This
decision follows persistent efforts to reliably secure the availability of the on-body delivery system.
Table 4: Phase III trials started since 1 January 2023
Medicine Trial name Indication
23 Metastatic castration-resistant prostate cancer.
24 Human epidermal growth factor receptor mutant.
25 Chronic lymphocytic leukaemia.
26 Heart failure with preserved ejection fraction.
27 Atypical haemolytic uraemic syndrome.
28 Paroxysmal nocturnal haemoglobinuria.
===== SIDA 6 =====
6
datopotamab
deruxtecan
AVANZAR NSCLC (1st-line)
TROPION-Lung07 Non-squamous NSCLC (1st-line)
camizestrant
CAMBRIA-1 HR-positive/HER2-negative adjuvant breast cancer
CAMBRIA-2 HR-positive/HER2-negative adjuvant breast cancer
capivasertib CAPItello-292 HR-positive/HER2-negative advanced br east cancer
volrustomig
eVOLVE-Cervical High-risk locally advanced cervical cancer
eVOLVE-Lung02 mNSCLC (1st-line) with PD-L1 29 <50%
zibo/dapa ZENITH High Proteinuria CKD 30 and high proteinuria
Saphnelo DAISY Systemic sclerosis
Tezspire CROSSING Eosinophilic oesophagitis
Breztri LITHOS Mild to moderate asthma
Breztri ATHLOS COPD 31
pMDI 32 portfolio HFO1234ze Mucociliary clearance in healt hy volunteers
pMDI portfolio HFO1234ze Well-controlled or partial ly-controlled asthma
tozorakimab MIRANDA Symptomatic COPD
AZD3152 SUPERNOVA COVID-19 prophylaxis
Ultomiris ARTEMIS Cardiac surgery-associated acute kidney injury
Corporate and business development
In September, AstraZeneca and Verge Genomics (Verge ) announced a multi-target collaboration to identif y
novel drug targets for rare neurodegenerative and n euromuscular diseases. Verge is a clinical-stage dr ug
discovery company using artificial intelligence and patient tissue data. Under the terms of the four-y ear
agreement, Verge will receive up to $42 million, consisting of upfront fee, equity, and near-term payments, with
potential downstream royalties. AstraZeneca will take an equity position in Verge.
In September, AstraZeneca completed the definitive purchase and licence agreement for a portfolio of
preclinical rare disease gene therapy programmes an d enabling technologies from Pfizer Inc. The agreement
has a total consideration of up to $1bn, plus tiered royalties on sales.
Cellectis
In November, AstraZeneca announced a collaboration and investment agreement with Cellectis, a clinical-stage
biotechnology company, to accelerate the developmen t of next generation therapeutics in areas of high unmet
need, including oncology, immunology and rare disea ses. Under the terms of the collaboration agreement ,
AstraZeneca will leverage the Cellectis proprietary gene editing technologies and manufacturing capabilities, to
design novel cell and gene therapy products, streng thening AstraZeneca's growing offering in this spac e. As
part of the agreement, 25 genetic targets have been exclusively reserved for AstraZeneca, from which up to 10
candidate products could be explored for development.
In Q4 2023, Cellectis will receive an initial payme nt of $105m from AstraZeneca, which comprises a $25 m
upfront cash payment under the terms of a research collaboration agreement and an $80m equity investme nt.
A further $140m equity investment is expected to cl ose in early 2024 subject to the signing of a final binding
agreement. Post-closing of this second investment, AstraZeneca will hold a total equity stake of appro ximately
44% in Cellectis. Under the terms of the research c ollaboration, Cellectis is also eligible to receive an
investigational new drug option fee and development, regulatory and sales-related milestone payments, ranging
from $70m up to $220m, per each of the 10 candidate products, plus tiered royalties.
Eccogene licence
29 Programmed death-ligand 1.
30 Chronic kidney disease.
31 Chronic obstructive pulmonary disease.
32 Pressure metered dose inhaler.
===== SIDA 7 =====
7
In November, AstraZeneca and Eccogene entered into an exclusive licence agreement for ECC5004, an
investigational oral once-daily glucagon-like peptide 1 receptor agonist (GLP-1RA) for the treatment of obesity,
type-2 diabetes and other cardiometabolic conditions . Preliminary results from the Phase I trial have s hown a
differentiating clinical profile for ECC5004, with good tolerability and encouraging glucose and body weight
reduction across the dose levels tested compared to placebo.
Under the terms of the agreement, Eccogene will rec eive an initial upfront payment of $185m and up to an
additional $1.825bn in future clinical, regulatory, and commercial milestones and tiered royalties. As traZeneca
is granted exclusive global rights for the developm ent and commercialisation of ECC5004 for any indica tion in
all territories except China, where Eccogene has th e right to co-develop and co-commercialise alongsid e
AstraZeneca.
Sustainability summary
This quarter AstraZeneca entered into long-term ren ewable energy partnerships in the UK and Sweden. Th e
UK agreement will support the transition away from fossil fuels at Company sites in Macclesfield, Camb ridge,
Luton and Speke. The Sweden agreement corresponds to approximately 80 percent of total electricity needs at
both the Company's Gothenburg site and at Södertälj e, one of the world's largest drug manufacturing ce ntres.
See the Sustainability section for further details.
Conference call
A conference call and webcast for investors and analysts will begin today, 9 November 2023, at 14:00 UK time.
Details can be accessed via astrazeneca.com.
Reporting calendar
The Company intends to publish its full year and fourth quarter results on Thursday 8 February 2024.
Operating and financial review
All narrative on growth and results in this section is based on actual foreign exchange rates, and financial figures
are in US$ millions ($m), unless stated otherwise. The performance shown in this announcement covers t he
nine-month period to 30 September 2023 (‘the period ' or ‘9M 2023') compared to the nine-month period t o 30
September 2022 (‘9M 2022'), or the three-month peri od to 30 September 2023 (‘the quarter' or ‘Q3 2023' )
compared to the three-month period to 30 September 2022 (‘Q3 2022'), unless stated otherwise.
Core financial measures, EBITDA, Net debt, Product Sales Gross Margin (formerly termed as Gross Margin ),
Operating Margin and CER are non-GAAP financial measures because they cannot be derived directly from the
Group's Interim financial statements. Management be lieves that these non-GAAP financial measures, when
provided in combination with Reported results, prov ide investors and analysts with helpful supplementa ry
information to understand better the financial perf ormance and position of the Group on a comparable b asis
from period to period. These non-GAAP financial mea sures are not a substitute for, or superior to, fin ancial
measures prepared in accordance with GAAP.
Core financial measures are adjusted to exclude certain significant items, such as:
‒ Amortisation and impairment of intangible assets, including impairment reversals but excluding any charges
relating to IT assets
‒ Charges and provisions related to restructuring pr ogrammes, which includes charges that relate to the impact
of restructuring programmes on capitalised IT assets
‒ Alexion acquisition-related items, primarily fair value adjustments on acquired inventories and fair value
impact of replacement employee share awards
‒ Other specified items, principally the imputed fin ance charges and fair value movements relating to
contingent consideration on business combinations o r asset acquisitions, imputed finance charges and
remeasurement adjustments on certain Other payables arising from intangible asset acquisitions, legal
settlements and remeasurement adjustments relating to Other payables assumed from the Alexion
acquisition
‒ The tax effects of the adjustments above are exclu ded from the Core Tax charge
===== SIDA 8 =====
8
Details on the nature of Core financial measures are provided on page 63 of the Annual Report and Form 20-F
Information 2022 .
Reference should be made to the Reconciliation of R eported to Core financial measures table included i n the
financial performance section in this announcement.
Product Sales Gross Margin (formerly termed Gross Margin) is the percentage by which Product Sales exceeds
the Cost of Sales, calculated by dividing the diffe rence between the two by the sales figure. The calc ulation of
Reported and Core Product Sales Gross Margin exclud es the impact of Alliance Revenue and Collaboration
Revenue and any associated costs, thereby reflecting the underlying performance of Product Sales.
EBITDA is defined as Reported Profit before tax aft er adding back Net finance expense, results from Jo int
ventures and associates and charges for Depreciation, amortisation and impairment. Reference should be made
to the Reconciliation of Reported Profit before tax to EBITDA included in the financial performance se ction in
this announcement.
Operating Margin is defined as Operating profit as a percentage of Total Revenue.
Net debt is defined as Interest-bearing loans and b orrowings and Lease liabilities, net of Cash and ca sh
equivalents, Other investments, and Net derivative financial instruments. Reference should be made to Note 3
‘Net debt' included in the Notes to the Interim financial statements in this announcement.
The Company strongly encourages investors and analy sts not to rely on any single financial measure, bu t to
review AstraZeneca's financial statements, includin g the Notes thereto, and other available Company re ports,
carefully and in their entirety.
Due to rounding, the sum of a number of dollar values and percentages in this announcement may not agree to
totals.
Total Revenue
Table 5: Therapy area and medicine performance - Product Sales and Total Revenue
9M 2023 Q3 2023
% Change % Change
Product Sales $m % Total Actual CER $m % Total Actual CER
Oncology 12,692 38 17 20 4,389 38 16 17
- Tagrisso 4,380 13 7 10 1,465 13 5 6
- Imfinzi 33 3,102 9 53 56 1,126 10 53 54
- Lynparza 2,070 6 6 9 702 6 7 8
- Calquence 1,839 5 25 26 654 6 16 15
- Enhertu 178 1 >3x >3x 73 1 >3x >3x
- Orpathys 33 - (3) 4 12 - 6 13
- Zoladex 699 2 (3) 5 239 2 - 5
- Faslodex 217 1 (16) (10) 64 1 (21) (16)
- Others 174 1 (36) (32) 54 - (33) (30)
BioPharmaceuticals: CVRM 7,887 23 14 18 2,683 23 14 16
- Farxiga 4,358 13 36 40 1,554 14 41 41
- Brilinta 996 3 (2) - 331 3 (2) (1)
- Lokelma 300 1 44 49 102 1 30 31
- roxadustat 208 1 41 51 74 1 31 39
- Andexxa 129 - 16 19 40 - (3) (5)
- Crestor 860 3 4 11 275 2 (1) 6
- Seloken/Toprol-XL 496 1 (30) (23) 153 1 (36) (29)
- Onglyza 180 1 (12) (8) 53 - (20) (17)
- Bydureon 123 - (40) (40) 35 - (48) (49)
- Others 237 1 (16) (13) 66 1 (23) (21)
BioPharmaceuticals: R&I 4,517 13 5 8 1,451 13 2 3
- Symbicort 1,842 5 (4) (1) 555 5 (12) (10)
- Fasenra 1,134 3 12 13 389 3 10 10
- Breztri 478 1 69 73 171 1 66 69
33 Product Sales shown in the Imfinzi line include Product Sales from Imjudo.
===== SIDA 9 =====
9
- Saphnelo 191 1 >2x >2x 76 1 >2x >2x
- Tezspire 51 - >10x >10x 21 - >10x >10x
- Pulmicort 493 1 3 10 148 1 2 7
- Bevespi 42 - (2) (2) 13 - (5) (4)
- Daliresp/Daxas 41 - (74) (74) 11 - (79) (79)
- Others 245 1 (30) (27) 67 1 (31) (28)
BioPharmaceuticals: V&I 667 2 (82) (81) 224 2 (74) (74)
- COVID-19 mAbs 34 126 - (91) (90) - - n/m n/m
- Vaxzevria 28 - (98) (98) - - n/m n/m
- Beyfortus 52 - n/m n/m 50 - n/m n/m
- Synagis 383 1 - 6 99 1 (5) (1)
- FluMist 78 - 32 28 75 1 28 23
Rare Disease 5,793 17 11 12 1,974 17 13 14
- Soliris 2,429 7 (17) (15) 781 7 (13) (12)
- Ultomiris 2,141 6 56 58 777 7 50 49
- Strensiq 847 3 23 24 285 2 20 21
- Koselugo 246 1 65 65 87 1 81 81
- Kanuma 130 - 17 18 44 - 21 19
Other Medicines 910 3 (27) (22) 297 3 (27) (22)
- Nexium 735 2 (25) (20) 244 2 (22) (17)
- Others 175 1 (33) (31) 53 - (43) (41)
Product Sales 32,466 96 1 4 11,018 96 4 5
Alliance Revenue 1,004 3 99 99 377 3 76 75
Collaboration Revenue 317 1 (28) (28) 97 1 (46) (47)
Total Revenue 33,787 100 2 5 11,492 100 5 6
Table 6: Alliance Revenue
9M 2023 Q3 2023
% Change % Change
$m % Total Actual CER $m % Total Actual CER
Enhertu 741 74 >2x >2x 266 70 66 65
Tezspire 179 18 >4x >4x 74 20 >2x >2x
Vaxzevria : royalties - - n/m n/m - - n/m n/m
Other royalty income 59 6 16 15 18 5 10 9
Other Alliance Revenue 25 2 >2x >2x 19 5 >3x >3x
Total 1,004 100 99 99 377 100 76 75
Table 7: Collaboration Revenue
9M 2023 Q3 2023
% Change % Change
$m % Total Actual CER $m % Total Actual CER
COVID-19 mAbs: licence fees 180 57 n/m n/m - - n/m n/m
Farxiga : sales milestones 28 9 n/m n/m 3 3 n/m n/m
tralokinumab: sales milestones 20 6 (82) (82) 20 21 (50) (50)
Lynparza : regulatory milestones - - n/m n/m - - n/m n/m
Beyfortus : regulatory milestones 71 22 n/m n/m 71 73 n/m n/m
Other Collaboration Revenue 18 6 (76) (76) 3 3 (95) (95)
Total 317 100 (28) (28) 97 100 (46) (47)
Table 8: Total Revenue by therapy area
9M 2023 Q3 2023
% Change % Change
$m % Total Actual CER $m % Total Actual CER
Oncology 13,458 40 17 20 4,664 41 15 17
BioPharmaceuticals 13,599 40 (10) (7) 4,548 40 (4) (2)
34 COVID-19 monoclonal antibodies.
===== SIDA 10 =====
10
- CVRM 7,926 23 14 19 2,687 23 14 16
- R&I 4,729 14 6 9 1,549 13 3 5
- V&I 944 3 (74) (73) 312 3 (64) (65)
Rare Disease 5,793 17 11 12 1,974 17 13 14
Other Medicines
937 3 (30) (26) 306 3 (36) (32)
Total
33,787 100 2 5 11,492 100 5 6
Table 9: Total Revenue by region
9M 2023 Q3 2023
% Change % Change
$m % Total Actual CER $m % Total Actual CER
US 13,940 41 6 6 4,859 42 5 4
Emerging Markets 9,242 27 3 10 2,964 26 4 12
- China 4,495 13 (2) 5 1,452 13 (6) 1
- Ex-China 4,747 14 8 15 1,513 13 15 25
Europe 6,765 20 5 5 2,392 21 16 9
Established RoW 3,840 11 (16) (9) 1,276 11 (10) (6)
Total 33,787 100 2 5 11,492 100 5 6
Table 10: Total Revenue by region - excluding COVID-19 medicines
9M 2023 Q3 2023
% Change % Change
$m % Total Actual CER $m % Total Actual CER
US 13,940 42 14 14 4,859 42 12 12
Emerging Markets 9,038 27 12 20 2,964 26 8 16
- China 4,495 13 (1) 6 1,452 13 (6) 1
- Ex-China 4,544 14 28 37 1,513 13 25 36
Europe 6,748 20 14 14 2,392 21 23 16
Established RoW 3,726 11 - 8 1,276 11 5 10
Total 33,453 100 12 15 11,492 100 12 13
Oncology
Oncology Total Revenue of $13,458m in 9M 2023 increased by 17% (20% at CER), representing 40% of overall
Total Revenue (9M 2022: 35%). There was no Lynparza Collaboration Revenue in 9M 2023 (9M 2022: $250m),
and Enhertu Alliance Revenue was $741m (9M 2022: $335m). Product Sales increased by 17% (20% at CER)
in 9M 2023 to $12,692m, reflecting new launches and expanded reimbursement across key brands; partiall y
offset by declines in legacy medicines.
Tagrisso
Total Revenue Worldwide US Emerging Markets Europe Established RoW
9M 2023 $m 4,380 1,679 1,261 821 619
Actual change 7% 14% 4% 6% (4%)
CER change 10% 14% 11% 6% 5%
Region Drivers and commentary
Worldwide ∗ Increased global demand for Tagrisso in adjuvant and 1st-line settings combined with
expanded reimbursement in the adjuvant setting
US ∗ Continued growth in demand in 1st-line and adjuvant settings
Emerging Markets ∗ Growing demand in adjuvant and 1st-line settings offset by impact of NRDL 35 renewal
price in China effective March 2023, some additional impact in China in the third quarter
resulting from reduced promotional activities following the government campaign
announced at the end of July 2023
35 National reimbursement drug list.
===== SIDA 11 =====
11
Europe ∗ Increased demand growth in 1st-line and growing adjuvant demand
Established RoW ∗ Increased demand in 1st-line and adjuvant settings offset by mandatory price reduction in
Japan effective June 2023
Imfinzi and Imjudo
Total Revenue Worldwide US Emerging Markets Europe Established RoW
9M 2023 $m 3,102 1,708 270 547 577
Actual change 53% 55% 20% 36% 90%
CER change 56% 55% 31% 35% >2x
Region Drivers and commentary
Worldwide ∗ Includes $161m of Total Revenue from Imjudo, which launched in Q4 2022 following
approvals in the US for patients with unresectable liver cancer (HIMALAYA) and Stage IV
NSCLC (POSEIDON)
∗ Growth across all regions, driven by recent launches (BTC 36 , HCC 37 , Stage IV NSCLC)
and established indications (Stage III NSCLC, SCLC 38 )
US ∗ Continued demand growth for BTC and HCC indications, increased uptake in SCLC
Emerging Markets ∗ Growth across markets driven by BTC launches and recovery of diagnosis and treatment
rates following the COVID-19 pandemic, slightly offset by decreased promotional activities
in China due to the government campaign announced at the end of July 2023
Europe ∗ Competitive share gain in SCLC, and expanded reimbursement for new launch indications
(BTC, HCC and Stage IV NSCLC)
Established RoW ∗ Growth driven by launch of HCC and BTC and increased share across indications in
Japan
Lynparza
Total Revenue Worldwide US Emerging Markets Europe Established RoW
9M 2023 $m 2,070 902 409 543 216
Actual change (6%) 1% 14% (27%) 7%
CER change (3%) 1% 24% (27%) 16%
Product Sales Worldwide US Emerging Markets Europe Established RoW
9M 2023 $m 2,070 902 409 543 216
Actual change 6% 1% 14% 10% 7%
CER change 9% 1% 24% 10% 16%
Region Drivers and commentary
Worldwide ∗ Lynparza remains the leading medicine in the PARP 39 inhibitor class globally across four
tumour types (ovarian, breast, prostate, pancreatic), as measured by total prescription
volume
∗ No regulatory milestones received in the period
US ∗ Continued share growth within the PARP inhibitor class, offset by declining class use and
the label restriction in 2nd-line ovarian cancer effective September 2023
Emerging Markets ∗ Increased demand, offset by price reduction in China associated with NRDL renewal that
took effect March 2023 for ovarian cancer indications (PSR 40 and BRCAm 41 1st-line
maintenance) and new NRDL enlistment in prostate cancer (PROfound) as well as some
impact in the third quarter resulting from reduced promotional activities following the
government campaign announced end of July 2023
36 Biliary tract cancer.
37 Hepatocellular carcinoma.
38 Small cell lung cancer.
39 Poly ADP ribose polymerase.
40 Platinum sensitive relapse.
41 Breast cancer gene mutation.
===== SIDA 12 =====
12
Europe ∗ Demand growth from increased uptake in 1st-line HRD-positive ovarian cancer,
gBRCAm 42 HER2-negative early breast cancer and mCRPC, offset by reduced use in 2nd-
line ovarian cancer and pricing
∗ Total Revenue in the prior year period included $250m of milestones
Established RoW ∗ Growth driven by increased uptake in testing and use in 1st-line HRD-positive ovarian
cancer
Enhertu
Total Revenue Worldwide US Emerging Markets Europe Established RoW
9M 2023 $m 919 518 179 204 17
Actual change >2x >2x >3x >2x >3x
CER change >2x >2x >3x >2x >3x
Region Drivers and commentary
Worldwide ∗ Combined sales of Enhertu , recorded by Daiichi Sankyo Company Limited (Daiichi
Sankyo) and AstraZeneca, amounted to $1,844m in 9M 2023 (9M 2022: $750m)
∗ AstraZeneca's Total Revenue of $919m in the period includes $741m of Alliance Revenue
from its share of gross profit and royalties in territories where Daiichi Sankyo records
product sales
US ∗ US in-market sales, recorded by Daiichi Sankyo, amounted to $1,087m in 9M 2023 (9M
2022: $532m)
∗ Increased demand across launched indications. Q3 2023 impacted by HER2-low bolus
depletion
Emerging Markets ∗ Continued uptake driven by recent approvals and launches including strong demand
growth in China following HER2-positive and HER2-low breast cancer launches
Europe ∗ Continued growth driven by increasing adoption in HER2-positive and HER2-low
metastatic breast cancer
Established RoW ∗ In Japan, AstraZeneca receives a mid-single-digit percentage royalty on sales made by
Daiichi Sankyo
Calquence
Total Revenue Worldwide US Emerging Markets Europe Established RoW
9M 2023 $m 1,839 1,337 69 353 80
Actual change 25% 12% >2x 76% 64%
CER change 26% 12% >2x 77% 74%
Region Drivers and commentary
Worldwide ∗ Increased penetration globally; leading BTKi 43 in key markets
US ∗ Leadership maintained in growing BTKi class, sustained leading share in the front-line
setting, offset by some competitive impact in relapsed refractory setting and increased
utilisation of free goods program in Q3
EU ∗ Solid growth continued amidst growing competitive pressure
∗ Increased new patients starts following expanded access in key markets
Orpathys
Orpathys Total Revenue of $34m declined 1% (6% incr ease at CER), (9M 2022: $35m), following its inclus ion
in the updated NRDL in China from March 2023, for t he treatment of patients with NSCLC with MET exon 1 4
skipping alterations.
Other Oncology medicines
9M 2023 Change
42 Germline (hereditary) breast cancer gene mutation.
43 Bruton tyrosine kinase inhibitor.
===== SIDA 13 =====
13
Total Revenue $m Actual CER
Zoladex 723 (2%) 5% ∗ Underlying growth due to continued demand growth in Emerging
Markets, partially offset by price reduction in China following
NRDL renewal
Faslodex 217 (16%) (10%) ∗ Generic competition
Other Oncology 174 (36%) (32%) ∗ Generic competition
BioPharmaceuticals
BioPharmaceuticals Total Revenue decreased by 10% (7% at CER) in 9M 2023 to $13,599m, representing 40%
of overall Total Revenue (9M 2022: 45%). The declin e was driven by COVID-19 medicines, partially offse t by
strong growth from Farxiga and newer R&I medicines .
BioPharmaceuticals - CVRM
CVRM Total Revenue increased by 14% (19% at CER) to $7,926m in 9M 2023, driven by the strong Farxiga
performance, and represented 23% of overall Total Revenue (9M 2022: 21%).
Farxiga
Total Revenue Worldwide US Emerging Markets Europe Established RoW
9M 2023 $m 4,389 1,000 1,655 1,356 378
Actual change 37% 34% 35% 42% 35%
CER change 41% 34% 43% 41% 45%
Region Drivers and commentary
Worldwide
∗ Farxiga volume is growing faster than the overall SGLT2 44 market in most major regions,
fuelled by launches in heart failure and CKD
∗ Additional benefit from continued growth in the overall SGLT2 inhibitor class
US ∗ Growth driven by heart failure and CKD for patients with and without T2D 45 resulting in an
increasing market share
Emerging Markets ∗ Solid growth despite generic competition in some markets
Europe ∗ Benefited from the addition of cardiovascular outcomes trial data to the label and growth in
HFrEF 46 , CKD and the HFpEF approval in February 2023. ESC 47 guidelines updated in
August 2023 to also include treatment of patients with HFpEF
∗ Continued strong volume growth in the quarter and expanded class leadership in several
key markets
Established RoW ∗ In Japan, AstraZeneca sells to collaborator Ono Pharmaceutical Co., Ltd, which records
in-market sales. Continued volume growth driven by HF and CKD launches. Generics
launched in Canada in the third quarter
Brilinta
Total Revenue Worldwide US Emerging Markets Europe Established RoW
9M 2023 $m 996 551 224 203 18
Actual change (2%) 2% 1% (5%) (54%)
CER change - 2% 10% (5%) (51%)
Region Drivers and commentary
US ∗ Sales in the third quarter benefitted from channel inventory movements
Emerging Markets ∗ Sales declined by 16% (4% at CER) in the third quarter driven by tender phasing
Europe ∗ Sales partly impacted by clawbacks
44 Sodium-glucose cotransporter 2.
45 Type-2 diabetes.
46 Heart failure with reserved ejection fraction.
47 European Society of Cardiology.
===== SIDA 14 =====
14
Established RoW ∗ Sales decline driven by generic entry in Canada
Lokelma
Lokelma Total Revenue increased 44% (49% at CER) to $300m with strong demand growth in all regions.
Roxadustat
Total Revenue increased 40% (50% at CER) to $212m, benefitting from increased demand in both the dialysis-
and non-dialysis-dependent populations
Andexxa
Andexxa Total Revenue increased 7% (9% at CER) to $129m.
Other CVRM medicines
9M 2023 Change
Total Revenue $m Actual CER
Crestor 862 4% 11% ∗ Continued sales growth in Emerging Markets, partly offset by
declines in the US and Established RoW
Seloken 496 (30%) (23%) ∗ Ongoing impact of China VBP implementation
Onglyza 180 (12%) (8%) ∗ Continued decline for DPP-IV class
Bydureon 123 (40%) (40%) ∗ Continued competitive pressures
Other CVRM 237 (16%) (13%)
BioPharmaceuticals - R&I
Total Revenue of $4,729m from R&I medicines in 9M 2 023 increased 6% (9% at CER) and represented 14%
of overall Total Revenue (9M 2022: 14%). This refle cted growth in Fasenra , Tezspire , Breztri and Saphnelo,
offsetting a decline in Symbicort and other mature brands .
Fasenra
Total Revenue Worldwide US Emerging Markets Europe Established RoW
9M 2023 $m 1,134 718 48 262 106
Actual change 12% 11% 62% 14% (1%)
CER change 13% 11% 69% 14% 6%
Region Drivers and commentary
Worldwide ∗ Retained market share leadership in severe eosinophilic asthma across major markets
US ∗ Expanded leadership in eosinophilic asthma and maintained total share in a growing
market, leading to double-digit volume growth, partially offset by managed market price
difference
Emerging Markets ∗ Continued strong volume growth driven by launch acceleration across key markets
Europe ∗ Expanded leadership in severe eosinophilic asthma, with strong volume growth partially
offset by price in some markets
Established RoW ∗ Maintained class leadership in Japan while market growth remained stable
Breztri
Total Revenue Worldwide US Emerging Markets Europe Established RoW
9M 2023 $m 478 263 123 55 37
Actual change 69% 60% 73% >2x 48%
CER change 73% 60% 86% >2x 58%
Region Drivers and commentary
===== SIDA 15 =====
15
Worldwide ∗ Continued to gain market share within the growing FDC 48 triple class across major markets
US ∗ Consistent share growth within the FDC triple class in new-to-brand 49 and the total market
Emerging Markets ∗ Maintained market share leadership in China with strong triple FDC class penetration
Europe ∗ Sustained growth across markets as new launches continue to progress
Established RoW ∗ Increased market share gains within COPD in Japan and strong launch performance in
Canada
Tezspire
Total Revenue Worldwide US Emerging Markets Europe Established RoW
9M 2023 $m 230 179 - 28 23
Actual change >5x >4x - n/m n/m
CER change >5x >4x - n/m n/m
Region Drivers and commentary
Worldwide ∗ Tezspire is approved in the US, EU and Japan (as well as other countries) for the
treatment of severe asthma without biomarker or phenotypic limitation
∗ Amgen records sales in the US, and AstraZeneca records its share of US gross profits as
Alliance Revenue. AstraZeneca books Product Sales in markets outside the US
∗ Combined sales of Tezspire by AstraZeneca and Amgen were $438m in 9M 2023
US ∗ Increased new-to-brand market share with majority of patients new to biologics
∗ Pre-filled pen approved in February 2023
Europe ∗ Achieved and maintained new-to-brand leadership in key markets
∗ Pre-filled pen approved in January 2023
Established RoW ∗ Japan maintained new-to-brand leadership
Saphnelo
Total Revenue Worldwide US Emerging Markets Europe Established RoW
9M 2023 $m 191 178 1 5 7
Actual change >2x >2x n/m >4x >3x
CER change >2x >2x n/m >4x >3x
Region Drivers and commentary
Worldwide ∗ Demand acceleration in the US, and additional growth driven by ongoing launches in
Europe and Japan
Symbicort
Total Revenue Worldwide US Emerging Markets Europe Established RoW
9M 2023 $m 1,842 589 600 408 245
Actual change (4%) (18%) 26% (8%) (12%)
CER change (1%) (18%) 36% (8%) (7%)
Region Drivers and commentary
Worldwide ∗ Symbicort remained the global market leader within a stable ICS 50 /LABA 51 class
US ∗ Generic competition entered the US market in the third quarter, leading to price and
volume share declines
Emerging Markets ∗ Strong underlying demand. Growth in China benefitted from the post-COVID-19 recovery
at the start of the year
Europe ∗ Continued price and volume erosion from generics and a slowing overall market
48 Fixed dose combination.
49 ‘New-to-brand’ share represents a medicine’s share in the dynamic market.
50 Inhaled corticosteroid.
51 Long-acting beta-agonist.
===== SIDA 16 =====
16
Established RoW ∗ Generic erosion in Japan
Other R&I medicines
9M 2023 Change
Total Revenue $m Actual CER
Pulmicort 493 3% 10% ∗ 80% of revenues from Emerging Markets
∗ China market share has stabilised, with VBP having been in effect
for over 12 months
Bevespi 42 (2%) (2%)
Daliresp 41 (74%) (74%) ∗ Impacted by uptake of multiple generics following loss of
exclusivity in the US
Other R&I 278 (41%) (38%) ∗ Collaboration Revenue of $20m (9M 2022: $110m)
∗ Product Sales of $245m decreased 30% (27% at CER) due to
generic competition
BioPharmaceuticals - V&I
Total Revenue from V&I medicines declined by 74% (7 3% at CER) to $944m (9M 2022: $3,673m) and
represented 3% of overall Total Revenue (9M 2022: 1 1%). In Q3 2023, no revenue was generated from
COVID-19 medicines.
COVID-19 mAbs
Total Revenue Worldwide US Emerging Markets Europe Established RoW
9M 2023 $m 306 - 185 7 114
Actual change (79%) n/m 11% (97%) (51%)
CER change (78%) n/m 11% (96%) (45%)
Region Drivers and commentary
Worldwide ∗ All Product Sales in 9M 2023 were derived from sales of Evusheld in the first quarter
Emerging Markets ∗ $180m license fee from Serum Institute of India in Q2 2023 recorded as Collaboration
Revenue
Vaxzevria
Total Revenue Worldwide US Emerging Markets Europe Established RoW
9M 2023 $m 28 - 18 10 -
Actual change (98%) n/m (98%) (97%) n/m
CER change (98%) n/m (98%) (97%) n/m
Region Drivers and commentary
Worldwide ∗ Revenue in the period decreased by 98% due to the conclusion of Vaxzevria contracts
Other V&I medicines
9M 2023 Change
Total Revenue $m Actual CER
Beyfortus 139 n/m n/m ∗ In Q3 2023 AstraZeneca reported $50m of Product Sales, $17m
of Alliance Revenue , and also $71m of Collaboration Revenue
relating to a regulatory milestone
∗ The Product Sales relates to sales to Sanofi of Beyfortus product
manufactured by AstraZeneca. In Q3 Product Sales benefitted
from stock building for the 2023-2024 RSV 52 season
∗ The Alliance Revenue consists of AstraZeneca's 50% share of
gross profits on sales of Beyfortus in major markets outside the
52 Respiratory syncytial virus.
===== SIDA 17 =====
17
US. AstraZeneca will also book 25% of revenues in rest of world
markets. AstraZeneca has no participation in US profits or losses
Synagis 383 - 6% ∗ Performance broadly in-line with prior year
FluMist 88 49% 45% ∗ $10m milestone received from Daiichi Sankyo in the second
quarter following FluMist approval in Japan
Rare Disease
Total Revenue from Rare Disease medicines increased by 11% (12% at CER) in 9M 2023 to $5,793m,
representing 17% of overall Total Revenue (9M 2022: 16%).
Performance was driven by the continued growth and durability of the C5 53 franchise, and also the strength of
Strensiq and Koselugo patient demand.
Ultomiris
Total Revenue Worldwide US Emerging Markets Europe Established RoW
9M 2023 $m 2,141 1,260 47 495 339
Actual change 56% 63% 38% 43% 54%
CER change 58% 63% 39% 42% 68%
Region Drivers and commentary
Worldwide ∗ Growth in neurology indications, expansion into new markets and continued conversion
from Soliris
∗ Quarter-on-quarter variability in revenue growth can be expected due to Ultomiris every
eight-week dosing schedule and lower average annual treatment cost per patient
compared to Soliris
US ∗ Growth in naïve patients in gMG 54 and NMOSD as well as successful conversion from
Soliris across shared indications
Emerging Markets ∗ Continued progress following launches in new markets
Europe ∗ Strong demand generation following launches in new markets, particularly in neurology
indications, as well as accelerated conversion from Soliris in key markets
Established RoW ∗ Continued conversion from Soliris and strong demand following new launches, particularly
NMOSD in Japan
Soliris
Total Revenue Worldwide US Emerging Markets Europe Established RoW
9M 2023 $m 2,429 1,313 338 530 248
Actual change (17%) (22%) 55% (15%) (36%)
CER change (15%) (22%) 74% (15%) (31%)
Region Drivers and commentary
US ∗ Decline driven by successful conversion of Soliris patients to Ultomiris in PNH, aHUS and
gMG, partially offset by Soliris growth in NMOSD
Emerging Markets ∗ Continued progress, launching in new markets
Europe,
Established RoW
∗ Decline driven by successful conversion from Soliris to Ultomiris , partially offset by growth
in NMOSD
Strensiq
Total Revenue Worldwide US Emerging Markets Europe Established RoW
9M 2023 $m 847 690 29 64 64
Actual change 23% 26% 14% 9% 12%
CER change 24% 26% 16% 8% 22%
53 Complement component 5.
54 Generalised myasthenia gravis.
===== SIDA 18 =====
18
Region Drivers and commentary
Worldwide ∗ Strong patient demand particularly in the US and Japan
Other Rare Disease medicines
9M 2023 Change
Total Revenue $m Actual CER Commentary
Koselugo 246 65% 65% ∗ Driven by patient demand and expansion in new markets
Kanuma 130 17% 18% ∗ Continued demand growth in ex-US markets
Other medicines (outside the main therapy areas)
9M 2023 Change
Total Revenue $m Actual CER Commentary
Nexium 748 (30%) (25%) ∗ Generic launches in Japan in the latter part of 2022
Others 189 (31%) (29%) ∗ Continued impact of generic comp etition
Financial performance
Table 11: Reported Profit and Loss
9M 2023 9M 2022 % Change Q3 2023 Q3 2022 % Change
$m $m Actual CER $m $m Actual CER
Total Revenue 33,787 33,144 2 5 11,492 10,982 5 6
- Product Sales 32,466 32,200 1 4 11,018 10,590 4 5
- Alliance Revenue 1,004 504 99 99 377 214 76 75
- Collaboration Revenue 317 440 (28) (28) 97 178 (46) (47)
Cost of sales (5,960) (9,491) (37) (38) (2,095) (2,982) (30) (31)
Gross profit 27,827 23,653 18 22 9,397 8,000 17 20
Product Sales Gross Margin 81.6% 70.5% +11pp +12pp 81.0% 71.8% +9pp +10pp
Distribution expense (394) (380) 4 6 (129) (126) 2 2
% Total Revenue 1.2% 1.1% - - 1.1% 1.1% - -
R&D expense (7,862) (7,137) 10 12 (2,584) (2,458) 5 4
% Total Revenue 23.3% 21.5% -2pp -2pp 22.5% 22.4% - -
SG&A expense (13,845) (13,798) - 2 (4,800) (4,277) 12 12
% Total Revenue 41.0% 41.6% +1pp +1pp 41.8% 38.9% -3pp -2pp
OOI 55 & expense 1,233 325 >3x >3x 70 106 (34) (33)
% Total Revenue 3.6% 1.0% +3pp +3pp 0.6% 1.0% - -
Operating profit 6,959 2,663 >2x >2x 1,954 1,245 57 69
Operating Margin 20.6% 8.0% +13pp +14pp 17.0% 11.3% +6pp +7pp
Net finance expense (945) (936) 1 1 (291) (324) (9) (6)
Joint ventures and associates (12) (4) >2x >2x (11) 1 n/m n/m
Profit before tax 6,002 1,723 >3x >3x 1,652 922 79 91
Taxation (1,000) 668 n/m n/m (274) 720 n/m n/m
Tax rate 17% -39% 17% -78%
Profit after tax 5,002 2,391 >2x >2x 1,378 1,642 (16) (6)
Earnings per share $3.22 $1.54 >2x >2x $0.89 $1.06 (16) (6)
Table 12: Reconciliation of Reported Profit before tax to EBITDA
55 Other Operating Income.
===== SIDA 19 =====
19
9M 2023 9M 2022 % Change Q3 2023 Q3 2022 % Change
$m $m Actual CER $m $m Actual CER
Reported Profit before tax 6,002 1,723 >3x >3x 1,652 922 79 91
Net finance expense 945 936 1 1 291 324 (9) (6)
Joint ventures and associates 12 4 >2x >2x 11 (1) n/m n/m
Depreciation, amortisation and
impairment
4,060 4,000 2 3 1,282 1,334 (4) (4)
EBITDA 11,019 6,663 65 77 3, 236 2,579 25 32
EBITDA for the comparative 9M 2022 was negatively impacted by $3,175m unwind of inventory fair value uplift
recognised on the acquisition of Alexion. EBITDA fo r the comparative Q3 2022 was negatively impacted b y
$857m unwind of inventory fair value uplift recogni sed on the acquisition of Alexion. This unwind had a $78m
negative impact on 9M 2023 and a $23m negative impa ct on Q3 2023. It will continue to be minimal and w ill
unwind fully over the next quarter.
Table 13: Reconciliation of Reported to Core financial measures: 9M 2023
9M 2023
Reported Restructuring
Intangible Asset
Amortisation &
Impairments
Acquisition
of Alexion Other 56 Core Core
% Change
$m $m $m $m $m $m Actual CER
Gross profit 27,827 133 24 82 (4) 28,062 4 8
Product Sales
Gross Margin
81.6% 82.4% +1pp +2pp
Distribution
expense
(394) - - - - (394) 4 6
R&D expense (7,862) 117 386 5 1 (7,353) 5 7
SG&A expense (13,845) 163 2,863 7 1,107 (9,705) 5 8
Total operating
expense
(22,101) 280 3,249 12 1,108 (17,452) 5 7
Other operating
income & expense
1,233 (61) - - - 1,172 >3x >3x
Operating profit 6,959 352 3,273 94 1,104 11,782 10 16
Operating Margin 20.6% 34.9% +2pp +3pp
Net finance
expense
(945) - - - 220 (725) (1) (2)
Taxation (1,000) (81) (617) (22) (329) (2,049) 12 19
EPS $3.22 $0.17 $1.72 $0.05 $0.64 $5.80 10 17
Table 14: Reconciliation of Reported to Core financial measures: Q3 2023
Q3 2023
Reported Restructuring
Intangible Asset
Amortisation &
Impairments
Acquisition
of Alexion Other 57 Core Core
% Change
$m $m $m $m $m $m Actual CER
Gross profit 9,397 15 8 25 (1) 9,444 6 7
Product Sales
Gross Margin
81.0% 81.4% +1pp +1pp
Distribution
expense
(129) - - - - (129) 3 2
R&D expense (2,584) 48 49 2 - (2,485) 5 5
56 Other adjustments include fair-value adjustments r elating to contingent consideration on business com binations and other acquisition-
related liabilities, discount unwind on acquisition-related liabilities (see Note 4) and provision movements related to certain legal matters,
including a $510m charge to provisions relating to a legal settlement with BMS and Ono and a $425m charge to provisions relating to a
multidistrict litigation proceeding legal settlement in 9M 2023 (see Note 6).
57 Other adjustments include fair-value adjustments r elating to contingent consideration on business com binations and other acquisition-
related liabilities, discount unwind on acquisition-related liabilities (see Note 4) and provision movements related to certain legal matters,
including a $425m charge to provisions relating to a multidistrict litigation proceeding legal settlement in Q3 2023 (see Note 6).
===== SIDA 20 =====
20
SG&A expense (4,800) 61 957 3 424 (3,355) 6 7
Total operating
expense
(7,513) 109 1,006 5 424 (5,969) 6 6
Other operating
income & expense
70 - - - - 70 (35) (34)
Operating profit 1,954 124 1,014 30 423 3,545 4 9
Operating Margin 17.0% 30.8% - +1pp
Net finance
expense
(291) - - - 68 (223) (12) (7)
Taxation (274) (29) (189) (7) (125) (624) 8 13
EPS $0.89 $0.06 $0.53 $0.01 $0.24 $1.73 4 9
Profit and Loss drivers
Gross profit
‒ The calculation of Reported and Core Product Sales Gross Margin excludes the impact of Alliance Revenue
and Collaboration Revenue. The change in Product Sa les Gross Margin (Reported and Core) in the nine
months was impacted by:
‒ Positive effects from product mix. The increased c ontribution from Rare Disease and Oncology medicines
had a positive impact on the Product Sales Gross Margin. Vaxzevria sales , which are dilutive to Product
Sales Gross Margin, declined substantially
‒ Dilutive effects from product mix. The rising cont ribution of Product Sales with profit sharing arrangements
(Lynparza, Enhertu and Tezspire) has a negative impact on Product Sales Gross Margi n because
AstraZeneca records product revenues in certain markets but pays away a share of the gross profit to its
collaboration partners
‒ Dilutive effects from geographic mix. Emerging Mar kets, where Product Sales Gross Margin tends to be
below the Company average, grew as a proportion of Total Revenue excluding COVID-19 medicines
‒ Variations in Product Sales Gross Margin performan ce between periods can continue to be expected due to
product seasonality, foreign exchange fluctuations and other effects.
R&D expense
‒ The change in R&D expense (Reported and Core) in t he period was impacted by:
‒ Recent positive data read-outs for several high pr iority medicines that have ungated late-stage trials
‒ Investment in platforms, new technology and capabi lities to enhance R&D productivity
‒ Reported R&D expense was also impacted by intangib le asset impairments
SG&A expense
‒ The change in SG&A expense (Reported and Core) in the period was driven primarily by market
development activities for launches
‒ Reported SG&A expense was also impacted by amortis ation of intangible assets related to the Alexion
acquisition and other acquisitions and collaborations
‒ Reported SG&A expense was also impacted by a $510m charge to provisions relating to a legal settlement
in Q2 2023 with Bristol-Myers Squibb and Ono Pharma ceutical, and a $425m charge to provisions in Q3
2023 for product liability litigations related to Nexium and Prilosec . The prior nine month period was impacted
by a $775m legal settlement with Chugai Pharmaceutical Co. Ltd
Other operating income and expense
‒ Reported and Core Other operating income and expen se in the period included a $712m gain resulting from
an update to the contractual relationships for Beyfortus (nirsevimab), a $241m gain on the disposal of the
US rights to Pulmicort Flexhaler , and other disposal proceeds on the sale of tangib le assets, and royalties
on certain medicines
===== SIDA 21 =====
21
‒ In the third quarter Reported and Core Other opera ting income decreased by $36m and $37m respectively,
principally due to the discontinuation of brazikuma b development. Prior to this, AstraZeneca received
quarterly development contributions for brazikumab development from AbbVie, which were recognised as
Other operating income
Net finance expense
‒ Reported Net finance expense was impacted by the d iscount unwind on acquisition-related liabilities. Core
Net finance expense reduced by 1% (2% at CER) with higher interest received on cash and short-term
investments, broadly offset by higher rates on floating debt and bond issuances
Taxation
‒ The effective Reported Tax rate for the nine month s to 30 September 2023 was 17% (9M 2022: (39%)) and
the effective Core Tax rate was 19% (9M 2022: 18%). The Q3 2022 effective Reported Tax rate was lower
as it included a one-time favourable adjustment of $883m relating to deferred taxes arising from an in ternal
reorganisation to integrate the Alexion business
‒ The cash tax paid for the nine months to 30 Septem ber 2023 was $1,710m (9M 2022: $1,335m),
representing 28% of Reported Profit before tax (9M 2022: 77%)
‒ On 20 June 2023, Finance (No.2) Act 2023 was subst antively enacted in the UK, introducing a global
minimum effective tax rate of 15%. The legislation implements a domestic top-up tax and a multinational top-
up tax, effective for accounting periods starting o n or after 31 December 2023. The Company is current ly
assessing the impact of these rules upon its financ ial statements. The Company has applied the except ion
under the IAS 12 ‘Income Taxes' amendment for recog nising and disclosing information about deferred ta x
assets and liabilities related to top-up income taxes
Table 15: Cash Flow summary
9M 2023 9M 2022 Change
$m $m $m
Reported Operating profit 6,959 2,663 4,296
Depreciation, amortisation and impairment 4,060 4,000 60
Decrease in working capital and short-term provisions 150 3,458 (3,308)
Gains on disposal of intangible assets (247) (88) (159)
Fair value movements on contingent consideration arising from
business combinations
202 293 (91)
Non-cash and other movements (623) (973) 350
Interest paid (826) (608) (218)
Taxation paid (1,710) (1,335) (375)
Net cash inflow from operating activities 7,965 7,410 555
Net cash inflow before financing activities 4,978 4,699 279
Net cash outflow from financing activities (6,276 ) (6,465 ) 189
In 9M 2022, the Reported Operating profit of $2,663 m included a negative impact of $3,175m relating to the
unwind of the inventory fair value uplift recognise d on the acquisition of Alexion. This was offset by a
corresponding item (positive impact of $3,175m) in Decrease in working capital and short-term provisio ns.
Overall, the unwind of the fair value uplift had no impact on Net cash inflow from operating activities. This unwind
had $78m negative impact on 9M 2023 Reported Operat ing profit and offsetting positive impact on Workin g
capital movements, and will continue to be minimal in the next quarter. As a result of the update to t he
contractual relationships between AstraZeneca, Sobi and Sanofi relating to the future sales of Beyfortus
(nirsevimab) in the US, a gain of $712m has been re corded in non-cash and other movements, with no ove rall
net impact on the Net cash inflow from operating activities.
Included within Net cash inflow before financing ac tivities is a movement in the profit-participation liability of
$190m, including a cash receipt from Sobi in Q1 202 3 after achievement of a regulatory milestone. The
associated cash flow is presented within investing activities.
The decrease in Net cash outflow from financing activities of $189m is primarily driven by the Issue of loans and
borrowings of $3,816m, offset by the increase in Repayment of loans and borrowings of $3,394m.
===== SIDA 22 =====
22
Capital expenditure
Capital expenditure amounted to $836m in the nine months to 30 September 2023 (9M 2022: $719m).
Table 16: Net debt summary
At 30
Sep 2023
At 31
Dec 2022
At 30
Sep 2022
$m $m $m
Cash and cash equivalents 4,871 6,166 4,458
Other investments 244 239 440
Cash and investments 5,115 6,405 4,898
Overdrafts and short-term borrowings (515) (350) (743)
Lease liabilities (979) (953) (878)
Current instalments of loans (4,857) (4,964) (4,665)
Non-current instalments of loans (22,225) (22,965) (23,013)
Interest-bearing loans and borrowings (Gross debt) (28,576) (29,232) (29,299)
Net derivatives 90 (96) (141)
Net debt (23,371) (22,923) (24,542)
Net debt increased by $448m in the nine months to 30 September 2023 to $23,371m. Details of the committed
undrawn bank facilities are disclosed within the go ing concern section of Note 1. Details of the Compa ny's
solicited credit ratings and further details on Net Debt are disclosed in Note 3.
Capital allocation
The Board's aim is to continue to strike a balance between the interests of the business, financial creditors and
the Company's shareholders. The Company's capital allocation priorities include: investing in the business and
pipeline; maintaining a strong, investment-grade credit rating; potential value-enhancing business development
opportunities; and supporting the progressive dividend policy.
In approving the declaration of dividends, the Board considers both the liquidity of the company and the level of
reserves legally available for distribution. Divide nds are paid to shareholders from AstraZeneca PLC, a Group
holding company with no direct operations. The ability of AstraZeneca PLC to make shareholder distributions is
dependent on the creation of profits for distributi on and the receipt of funds from subsidiary compani es. The
consolidated Group reserves set out in the Condensed consolidated statement of financial position do not reflect
the profit available for distribution to the shareholders of AstraZeneca PLC.
Summarised financial information for guarantee of securities of subsidiaries
AstraZeneca Finance LLC ("AstraZeneca Finance”) is the issuer of 0.700% Notes due 2024, 1.200% Notes due
2026, 4.875% Notes due 2028, 1.750% Notes due 2028, 4.900% Notes due 2030, 2.250% Notes due 2031 and
4.875% Notes due 2033 (the "AstraZeneca Finance Not es”). Each series of AstraZeneca Finance Notes has
been fully and unconditionally guaranteed by AstraZ eneca PLC. AstraZeneca Finance is 100% owned by
AstraZeneca PLC and each of the guarantees by Astra Zeneca PLC is full and unconditional and joint and
several.
The AstraZeneca Finance Notes are senior unsecured obligations of AstraZeneca Finance and rank equally
with all of AstraZeneca Finance's existing and future senior unsecured and unsubordinated indebtedness . The
guarantee by AstraZeneca PLC of the AstraZeneca Fin ance Notes is the senior unsecured obligation of
AstraZeneca PLC and ranks equally with all of Astra Zeneca PLC's existing and future senior unsecured a nd
unsubordinated indebtedness. Each guarantee by AstraZeneca PLC is effectively subordinated to any secured
indebtedness of AstraZeneca PLC to the extent of th e value of the assets securing such indebtedness. T he
AstraZeneca Finance Notes are structurally subordinated to indebtedness and other liabilities of the subsidiaries
of AstraZeneca PLC, none of which guarantee the AstraZeneca Finance Notes.
AstraZeneca PLC manages substantially all of its operations through divisions, branches and/or investments in
subsidiaries and affiliates. Accordingly, the abili ty of AstraZeneca PLC to service its debt and guara ntee
obligations is also dependent upon the earnings of its subsidiaries, affiliates, branches and division s, whether
by dividends, distributions, loans or otherwise.
===== SIDA 23 =====
23
Please refer to the consolidated financial statemen ts of AstraZeneca PLC in our Annual Report on Form 20-F
and reports on Form 6-K with our quarterly financia l results as filed or furnished with the SEC 58 for further
financial information regarding AstraZeneca PLC and its consolidated subsidiaries. For further details , terms
and conditions of the AstraZeneca Finance Notes ple ase refer to AstraZeneca PLC's reports on Form 6-K
furnished to the SEC on 3 March 2023 and 28 May 2021.
Pursuant to Rule 13-01 and Rule 3-10 of Regulation S-X under the Securities Act of 1933, as amended (t he
"Securities Act”), we present below the summary fin ancial information for AstraZeneca PLC, as Guaranto r,
excluding its consolidated subsidiaries, and AstraZ eneca Finance, as the issuer, excluding its consoli dated
subsidiaries. The following summary financial infor mation of AstraZeneca PLC and AstraZeneca Finance i s
presented on a combined basis and transactions betw een the combining entities have been eliminated.
Financial information for non-guarantor entities ha s been excluded. Intercompany balances and transact ions
between the obligor group and the non-obligor subsidiaries are presented on separate lines.
Table 17: Obligor group summarised Statement of comprehensive income
9M 2023 9M 2022
$m $m
Total Revenue - -
Gross profit - -
Operating loss (2) (3)
Loss for the period (695) (404)
Transactions with subsidiaries that are not issuers or guarantors 9,758 502
Table 18: Obligor group summarised Statement of financial position
At 30 Sep 2023 At 30 Sep 2022
$m $m
Current assets 6 5
Non-current assets - -
Current liabilities (4,760) (3,067)
Non-current liabilities (22,077) (22,556)
Amounts due from subsidiaries that are not issuers or guarantors 12,921 7,349
Amounts due to subsidiaries that are not issuers or guarantors (295) (301)
Foreign exchange
The Company's transactional currency exposures on working-capital balances, which typically extend for up to
three months, are hedged where practicable using fo rward foreign exchange contracts against the indivi dual
companies' reporting currency. Foreign exchange gai ns and losses on forward contracts for transactiona l
hedging are taken to profit or loss. In addition, t he Company's external dividend payments, paid princ ipally in
pounds sterling and Swedish krona, are fully hedged from announcement to payment date.
Table 19: Currency sensitivities
The Company provides the following currency-sensitivity information:
Average
rates vs. USD
Annual impact ($m) of
5% strengthening
(FY2023 average rate
vs. FY 2022 average) 59
58 Securities Exchange Commission.
59 Based on best prevailing assumptions around currency profiles.
===== SIDA 24 =====
24
Currency Primary Relevance FY
2022 60
YTD
2023 61
Change
(%)
Sep
2023 62
Change 63
(%)
Total
Revenue
Core
Operating
Profit
EUR Total Revenue 0.95 0.92 3 0.94 1 323 159
CNY Total Revenue 6.74 7.04 (4) 7.30 (8) 309 174
JPY Total Revenue 131.59 138.18 (5) 147.71 (11) 181 122
Other 64 385 202
GBP Operating expense 0.81 0.80 1 0.81 0 46 (92)
SEK Operating expense 10.12 10.59 (4) 11.08 (9) 7 (55)
Sustainability
Since the last quarterly report, AstraZeneca:
Access to healthcare
‒ Hosted the first dedicated side-event on Chronic K idney Disease (CKD) "How improving kidney health ca n
transform health systems for all” during the 78th United Nations General Assembly (UNGA) meeting in New
York, with public, private and patient voices repre sented. During UNGA, the Company also engaged with
the cancer community on access, services within uni versal health coverage (UHC) and the need for
investment in cancer and non-communicable diseases (NCDs)
‒ Continued to make a high-level contribution to the work of the Partnership for Health System Sustaina bility
and Resilience (PHSSR), which provides a valuable p latform for dialogue with policymakers, the Company
and other stakeholders. In Canada, a workshop with participation from the Minister of Health of Quebec fed
into the discussions on transformation of Quebec's health system. In Japan, AstraZeneca's Chair Michel
Demaré participated in a PHSSR roundtable co-hosted by the British Embassy, which focused on health
equity and digital healthcare. PHSSR also engaged a t leading global and regional healthcare events,
including the European Health Forum Gastein, the Global Congress on Population, Health and Development,
ICHOM 2023 and the World Health Summit in Berlin
‒ Ruud Dobber, EVP BioPharmaceuticals Business Unit, delivered the opening keynote address at the
POLITICO EU Healthcare Summit in Brussels where he called for bold action and collaboration across the
healthcare ecosystem to support early diagnosis and treatment. He highlighted the need for regulatory
frameworks that accelerate access to medical innovation, as well as the urgency to combat the effects of the
climate crisis on health
‒ Marked World Heart Day and the ninth anniversary o f Healthy Heart Africa (HHA)'s launch, by convening
African health stakeholders to take stock of the programme's achievements and share insights on the critical
role of public-private partnerships in supporting p rimary healthcare. Speakers included representative s of
Ministries of Health from nine countries and HHA implementing partners, with more than 70 attendees. HHA
has trained more than 11,000 healthcare workers and conducted over 43 million blood pressure screenings,
identifying 8.6 million with elevated blood pressur e since launch, moving closer to the programme ambi tion
of 10 million by 2025, and achieving one million sc reenings per month since February 2023 (data as at end
of September 2023)
‒ Young Health Programme is now active in 40 countri es, with new programmes launched in Costa Rica and
Taiwan. Through the Young Health Programme Impact Fellowship, the Company supported a delegation of
17 young health leaders from 13 countries to attend One Young World 2023 in Belfast. Three of these
changemakers joined AstraZeneca leadership in on-st age appearances, discussing their impact on NCD
prevention for young people in their communities. A straZeneca and Plan International UK were awarded
‘Highly Commended' at the Corporate Engagement Awards for Best Educational Programme
Environmental protection
60 Based on average daily spot rates 1 Jan 2022 to 31 Dec 2022.
61 Based on average daily spot rates 1 Jan 2023 to 30 Sep 2023.
62 Based on average daily spot rates 1 Sep 2023 to 30 Sep 2023.
63 Change vs. the average spot rate for the previous year
64 Other currencies include AUD, BRL, CAD, KRW and RUB.
===== SIDA 25 =====
25
‒ Entered into an agreement in Sweden with Statkraft , Europe's largest renewable energy producer, on wi nd
power deliveries that will increase the supply of r enewable electricity in Sweden. The agreement is ba sed
on the commissioning of new wind farms. Under the a greement, AstraZeneca commits to purchasing 200
gigawatt-hours per year for 10 years, equivalent to two terawatt-hours. This corresponds to approximat ely
80 percent of total electricity needs at both the C ompany's Gothenburg site and at Södertälje, the lar gest
manufacturing centre and one of the world's largest drug manufacturing centres
‒ Agreed a 15-year partnership with Future Biogas to establish the first unsubsidised industrial-scale supply
of biomethane in the UK. This biomethane will support the transition away from fossil fuels at Company sites
in Macclesfield, Cambridge, Luton and Speke. A new biomethane plant will add renewable energy capacity
to existing UK infrastructure and supply more than 100 gigawatt hours of biomethane, equivalent to the heat
needs of more than 8,000 homes. Using crops grown l ocally as part of diverse crop rotations, the plant will
also contribute to the development of a circular ec onomy, supporting UK farms with sustainable land
management practices
‒ In China, CEO Pascal Soriot and EVP and China Pres ident Leon Wang witnessed the launch of the
Sustainable Markets Initiative (SMI) China Council Health Working Group. Inspired by the SMI Health
Systems Task Force, members of this new partnership will collaborate to accelerate the delivery of a n et
zero health system, for domestic and global impact. AstraZeneca China will co-chair this Working Group ,
which comprises China-based organisations and Chinese affiliates of global pharmaceutical companies
‒ In the U.S., advocated for climate action and sust ainable healthcare reform during Climate Week NYC b y
convening high-level representatives from the US go vernment, WHO, civil society and philanthropy at a
plenary event with Climate Group on ”Addressing the climate-health-equity nexus: The path to a sustainable
future”. The Company also discussed accelerating health sector decarbonisation at the Forbes Sustainability
Leaders Summit in a session on "How the healthcare industry is responding to climate change" alongside
US National Academy of Medicine President Dr. Victo r J. Dzau. Furthermore, the Company participated in
an event on water stewardship
‒ Contributed to a joint report on Advancing water s tewardship through supplier collaboration in partne rship
with the World Wide Fund for Nature
‒ Ranked in first position for climate action in a n ew STAT Report "Climate rankings: How top drug companies
measure up in combating climate change”, which noted that "Companies like AstraZeneca are the exception
in an industry that, as a whole, could be doing muc h more to measure and report its climate impacts,
according to organizations that pool data on this topic”
‒ Received the EcoVadis Gold Medal for 2023, improvi ng on the 2022 Silver rating. AstraZeneca was score d
in four areas: Environment, Ethics, Labor and Human Rights, and Sustainable Procurement, and received
an Advanced rating in the Environment and Human Rights categories
‒ Recognised with two awards from My Green Lab and t he International Institute for Sustainable Laboratories'
in the 2023 Freezer Challenge: the Top Organization Award and the Small Size Lab Award for our site in
Gothenburg, Sweden
Ethics and transparency
‒ Received three supplier diversity awards from the Diversity for Science Alliance including 2023 Company of
the year
‒ Launched Global Ethics training ahead of Global Et hics Day in October, an annual reminder to employee s
of the Company's commitment to high ethical standards in all areas of AstraZeneca's business, marking the
day with local and virtual events and an #EmpoweringEthics employee social campaign
‒ Held an internal Power of Diversity panel discussi on with members of the Company's Global Inclusion &
Diversity (I&D) Council on the topic of putting an I&D lens over our AZ Values. This focused on buildi ng a
sense of belonging through allyship, mutual support and the sharing of diverse perspectives. Supportin g
materials were made available through employee communication channels
Research and development
This section covers R&D events and milestones that have occurred since the prior results announcement on
28 July 2023, up to and including events on 8 November 2023.
===== SIDA 26 =====
26
A comprehensive view of AstraZeneca's pipeline of medicines in human trials can be found in the latest Clinical
Trials Appendix, available on www.astrazeneca.com/i nvestor-relations. The Clinical Trials Appendix inc ludes
tables with details of the ongoing clinical trials for AstraZeneca medicines and new molecular entitie s in the
pipeline.
Oncology
AstraZeneca presented new data across its diverse p ortfolio of cancer medicines at two major medical
congresses during the quarter: the 2023 World Confe rence on Lung Cancer (WCLC) in September and the
2023 European Society of Medical Oncology (ESMO) in October. At WCLC, AstraZeneca presented more than
40 abstracts featuring eight approved and potential new medicines, including nine oral presentations and a late-
breaking plenary Presidential Symposium presentatio n of results from the FLAURA2 Phase III trial of Tagrisso
plus chemotherapy in 1st-line EGFR m NSCLC. At ESMO, AstraZeneca presented nearly 100 abstracts
featuring 19 approved and potential new medicines i ncluding 26 oral presentations and two late-breakin g
Presidential Symposia of the TROPION-Lung01 and TROPION-Breast 01 Phase III trials of monotherapy Dato-
DXd versus conventional chemotherapy in lung and breast cancers.
Tagrisso
Event Commentary
Breakthrough
Designation
US
Tagrisso in combination with chemotherapy for the treatment of adult patients with
locally advanced or metastatic EGFRm lung cancer. (FLAURA2, August 2023)
Presentation:
WCLC
FLAURA2
Interim analysis of the Phase III FLAURA2 trial, presented at WCLC, demonstrated
Tagrisso plus chemotherapy extended median PFS 65 by nearly nine months and
reduced the risk of disease progression by 38% in EGFRm advanced lung cancer
vs. Tagrisso monotherapy. (September 2023)
Priority Review US Tagrisso in combination with chemotherapy for the treatment of adult patients with
locally advanced or metastatic EGFRm lung cancer. (FLAURA2, October 2023)
Presentation:
ESMO
FLAURA2
CNS analysis
Prespecified exploratory analysis of the Phase III FLAURA2 trial, presented at
ESMO, showed Tagrisso plus chemotherapy demonstrated a 42% improvement
in CNS 66 PFS vs. Tagrisso monotherapy in patients with EGFRm advanced lung
cancer and brain metastases at baseline, representing 40% of patients in the trial,
as assessed by blinded independent central review. (October 2023)
Imfinzi and Imjudo
Event Commentary
Positive Opinion
EU
The Committee for Medicinal Products for Human Use (CHMP) issued a positive
opinion for Type II Extension of Indication Variation for Imfinzi as monotherapy for
the first line treatment of adults with advanced or unresectable HCC. (HIIMALAYA,
July 2023)
Presentation:
ESMO
MATTERHORN
Interim analysis of the Phase III MATTERHORN III tria l, presented at ESMO,
showed that Imfinzi in combination with standard-of-care FLOT 67 neoadjuvant
chemotherapy demonstrated a statistically significant and clinically meaningful 12%
improvement in the key secondary endpoint of pCR 68 vs. neoadjuvant
chemotherapy alone for patients with resectable, early-stage and locally gastric and
GEJ 69 cancers. (October 2023)
Phase III data
readout
EMERALD-1
Positive high-level results from the EMERALD-1 Phase III trial showed Imfinzi in
combination with TACE 70 and bevacizumab demonstrated a statistically significant
and clinically meaningful improvement in the primary endpoint of PFS versus TACE
65 Progression free survival.
66 Central nervous system.
67 Fluorouracil, oxaliplatin and docetaxel .
68 Pathologic complete response.
69 Gastro oesophageal junction.
70 Transarterial chemoembolisation.
===== SIDA 27 =====
27
alone in patients with HCC eligible for embolisation. The trial continues to follow the
secondary endpoint of OS 71 . (November 2023)
Lynparza
Event Commentary
Approval Japan Lynparza in combination with abiraterone and prednisolone f or the treatment of
adult patients with BRCAm mCRPC. (August 2023)
Label restriction US Restriction of the Lynparza indication for the maintenance treatment of adult
patients with recurrent epithelial ovarian, fallopi an tube, or primary peritoneal
cancer who are in a complete or partial response to platinum-based chemotherapy
to the BRCAm (germline or somatic) patient population only. (September 2023)
Presentation:
ESMO
DUO-E
(Lynparza and
Imfinzi )
Primary analysis of the Phase III DUO-E Phase III tr ial, presented at ESMO,
showed that treatment with Imfinzi plus chemotherapy followed by either Imfinzi
monotherapy or Imfinzi plus Lynparza demonstrated a reduction in the risk of
disease progression or death, by 45% and 29%, respe ctively, vs. chemotherapy
alone in patients with advanced or recurrent endometrial cancer. (October 2023)
Enhertu
Event Commentary
Approval Japan For the treatment of adult patients with unresectable advanced or recurrent NSCLC
with HER2 (ERBB2) mutations that has progressed afte r chemotherapy.
(DESTINY-Lung02, August 2023)
Breakthrough
Designation
US
For the treatment of adult patients with unresectable or metastatic HER2-positive
(IHC 72 3+) solid tumours that have progressed following p rior treatment and who
have no alternative treatment options. (DESTINY-PanTumor02, August 2023)
For the treatment of patients with HER2-positive (IH C 3+) metastatic colorectal
cancer who have received two or more prior regimens . (DESTINY-CRC01,
DESTINY-CRC02, August 2023)
Presentation:
WCLC
DESTINY-
Lung02
Results from the primary analysis of the DESTINY-Lung02 Phase II trial, presented
at WCLC, showed Enhertu provided a median PFS of 9.9 months at a dose of
5.4mg/kg, and 15.4 months at a dose of 6.4mg/kg, with a favourable safety profile
that confirm 5.4mg/kg is the optimal dose in this tumour type. (September 2023)
Approval EU As monotherapy for the treatment of adult patients with advanced NSCLC whose
tumours have an activating HER2 (ERBB2 73 ) mutation and who require systemic
therapy following platinum-based chemotherapy with or without immunotherapy.
(DESTINY-Lung02, October 2023)
Presentation:
ESMO
DESTINY-
PanTumor02
Primary analysis of the Phase II DESTINY-PanTumor02 trial, presented at ESMO,
showed that treatment with Enhertu resulted in confirmed ORR 74 of 37.1%, a
median PFS of 6.9 months and median OS of 13.4 mont hs in previously treated
patients across multiple HER2-expressing advanced solid tumours. (October 2023)
Calquence
Event Commentary
Approval China
For the treatment of adult patients with CLL or SLL 75 who have received at least
one prior therapy. (ASCEND, September 2023)
71 Overall survival.
72 Immunohistochemistry.
73 v-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2.
74 Overall response rate.
75 Small lymphocytic lymphoma.
===== SIDA 28 =====
28
datopotamab deruxtecan (Dato-Dxd)
Event Commentary
Presentation:
WCLC
TROPION-
Lung04
Results from a planned interim analysis of the Phas e Ib TROPION-Lung04 trial,
presented at WCLC, showed that Dato-DXd in combinatio n with Imfinzi , with or
without carboplatin demonstrated objective response rates of 77% and 50% and
disease control rates of 92% and 93% respectively, with no new safety signals in
patients with previously untreated advanced or meta static NSCLC without
actionable genomic alterations. (September 2023)
Presentation:
ESMO
BEGONIA
Updated results from the Phase Ib/II BEGONIA trial, presented at ESMO, showed
Dato-DXd plus Imfinzi demonstrated a confirmed objective response rate of 79%
and a median PFS of 13.8 months in patients with previously untreated advanced
or metastatic triple-negative breast cancer. (October 2023)
Presentation:
ESMO
TROPION-
Lung01
Primary analysis for the Phase III TROPION-Lung01 tr ial, presented at ESMO,
showed that Dato-DXd reduced the risk of disease progression or death by 25% in
the overall population and by 37% in non-squamous t umours vs. docetaxel in
patients with previously treated NSCLC. (October 2023)
Presentation:
ESMO
TROPION-
Breast01
Primary analysis for the Phase III TROPION-Breast01 trial, presented at ESMO,
showed that Dato-DXd reduced the risk of disease progression or death by 37%,
providing a two-month median PFS benefit, and was wel l tolerated in the post-
endocrine therapy setting vs. investigator's choice of chemotherapy in patients with
inoperable or metastatic HR-positive, HER2-low or HER2-negative breast cancer
previously treated with endocrine-based therapy and at least one systemic therapy.
(October 2023)
Other oncology pipeline
Event Commentary
Trial update MONETTE Phase II trial of ceralasertib + Imfinzi in unresectable or advanced melanoma and
resistance to PD-(L)1 inhibition stopped enrolment following a pre-specified futility
(efficacy) assessment. There were no concerning safety signals identified at this
interim analysis or during the two prior data review meetings.
Presentation:
ASCO Virtual
Plenary
NCT04805307 Interim analysis for the Phase I trial (NCT04805307) of CMG901 (Claudin 18.2
ADC 76 ) demonstrated promising clinical efficacy in patients with heavily pre-treated
CLDN18.2-positive gastric/GEJ cancer, with a manage able safety profile.
(November 2023)
BioPharmaceuticals - CVRM
AstraZeneca presented 19 abstracts, including 10 or al presentations and five late-breaking presentatio ns, at
the European Society of Cardiology (ESC) Congress in August, including data highlighting the opportunities for
improved management in heart failure, and AstraZeneca's leadership across the interconnectedness of chronic
diseases. At the American Society of Nephrology's ( ASN) Kidney Week in November, AstraZeneca presented
53 abstracts showcasing the strength of its portfol io, including new ZORA and REVOLUTIONIZE real-world
evidence data for Lokelma and compelling next-wave pipeline innovation with results from the ZENITH-CKD
Phase IIb trial for zibotentan/dapagliflozin.
Farxiga
Event Commentary
Approval
China
Approved in China to reduce the risk of cardiovascul ar death, hospitalisation for
HF 77 or urgent HF visits in adults with symptomatic chronic HF. (June 2023)
Data T2NOW Positive data from the Phase III T2NOW trial, demonstrating a significant reduction
in A1C in patients aged 10-17 years compared to pat ients receiving placebo.
(October 2023)
Data DAPA-MI Primary endpoint met, non-registrational trial. (August 2023)
76 Antibody drug conjugate.
77 Heart failure.
===== SIDA 29 =====
29
zibotentan/dapagliflozin
Event Commentary
Presentation:
ASN
ZENITH-CKD Phase IIb data showed statistically significant and clinically meaningful
reductions in urinary albumin-to-creatinine ratio ( UACR), used to assess
albuminuria, at 12 weeks compared with the standard of care of dapagliflozin
alone. After 12 weeks of treatment, the UACR differ ence of
zibotentan/dapagliflozin versus dapagliflozin alone was -33.7% (90% CI -42.5
to -23.5; p<0.001) for high-dose (1.5 mg zibotentan / 10 mg dapagliflozin) and -
27.0% (90% CI -38.4 to -13.6; p=0.002) for low dose (0.25 mg/10mg).
(November 2023)
Eplontersen
Event Commentary
Orphan Drug
Designation
EU
Orphan drug designation received for the treatment of ATTR 78 . (October 2023)
BioPharmaceuticals - R&I
AstraZeneca presented new data across its inhaled, biologic and early science respiratory portfolio at the
European Respiratory Society (ERS) International Congress 2023. The company presented over 90 abstract s,
including 18 oral presentations, which focused on unmet needs in severe asthma, chronic obstructive pulmonary
disease and other acute respiratory diseases. Data from Fasenra and Tezspire advanced clinical remission as
a treatment target to change the trajectory of severe asthma care.
Fasenra
Event Commentary
Phase III data
readout
MANDARA
Positive high-level results from the MANDARA Phase I II trial for Fasenra
demonstrated non-inferior rates of remission compared to mepolizumab in patients
with EGPA who were receiving oral corticosteroids w ith or without stable
immunosuppressive therapy. MANDARA was the first he ad-to-head trial of
biologics in EGPA, comparing a single monthly injec tion of Fasenra to three
injections per month of mepolizumab, the only curre ntly approved treatment.
(September 2023)
Presentation:
ERS
SHAMAL
SHAMAL assessed the ability of Fasenra to permit a progressive reduction from
high-dose ICS/LABA down to anti-inflammatory reliever whilst maintaining control
in SEA 79 pts who were well-controlled on Fasenra . Fasenra enabled the majority of
SEA patients to maintain disease control and remain exacerbation-free despite a
reduction in background therapy to anti-inflammator y reliever only. (September
2023)
Presentation:
ERS
MIRACLE
The positive MIRACLE Phase III trial demonstrated a reduction in annual asthma
exacerbation rate of 74% among patients in China wi th uncontrolled SEA vs.
placebo. A filing for regulatory approval in China has been submitted, with a
decision expected in H2 2024. (September 2023)
Tezspire
Event Commentary
Presentation:
ERS
DESTINATION
In a post-hoc exploratory analysis of the DESTINATION Phase III trial of patients
with severe, uncontrolled asthma, a numerically greater proportion of patients who
received tezepelumab than placebo achieved remissio n during the time periods
assessed. (September 2023)
78 Transthyretin-mediated amyloid cardiomyopathy and transthyretin-mediated amyloid polyneuropathy
79 Severe eosinophilic asthma.
===== SIDA 30 =====
30
BioPharmaceuticals - V&I
AZD3152
Event Commentary
Presentation:
ID Week
In-vitro
neutralisation
data
In vitro neutralisation data presented at ID Week showed th at AZD3152 potently
neutralises across a broad range of historical and contemporary SARS-CoV-2
variants, including the newly emerging BA.2.86 vari ant. AZD3152 loses activity
against XBB variants with the F456L mutation. (October 2023)
The SUPERNOVA Phase III efficacy trial, which is now fully enrolled, will assess
the potential benefit of AZD3152 in protecting immunocompromised patients in an
environment with many variants in circulation.
FluMist
Event Commentary
sBLA
submission
Self
administration
The FDA has accepted for review a sBLA for the approval of a self- or caregiver-
administered option for FluMist . If approved, FluMist will be the first flu vaccine
available to be self-administered by eligible patients or administered by caregivers.
The sBLA is supported by a usability study which confirmed that individuals over 18
years of age could self-administer or administer FluMist to eligible patients 2-49
years of age when given instructions for use withou t any additional guidance.
(October 2023)
Rare Disease
Alexion, AstraZeneca Rare Disease presented new real-world and clinical data at the European Committee for
Treatment and Research in Multiple Sclerosis and Americas Committee for Treatment and Research in Multiple
Sclerosis (ECTRIMS-ACTRIMS), offering further evide nce to support the established safety and efficacy of
Soliris and Ultomiris in treating NMOSD.
Alexion, AstraZeneca Rare Disease presented new cli nical data at the American Society of Nephrology (A SN)
for Ultomiris in IgAN 80 as well as real-world data in aHUS.
Alexion, AstraZeneca Rare Disease presented new real-world and clinical data at the American Association of
Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and Myasthenia Gravis Foundation of
America Scientific Session (MGFA SS). Data shared across 13 abstracts, reinforcing the safety and efficacy of
C5 inhibition in treating generalized myasthenia gravis (gMG).
Soliris
Event Commentary
Approval Japan Paediatric patients with gMG. (August 2023)
Approval China Adults with anti - aquaporin-4 antibody-positive NMOSD. (October 2023)
Ultomiris
Event Commentary
CRL US The US FDA issued a CRL 81 regarding the sBLA 82 for Ultomiris for the treatment of
adults with NMOSD. The sBLA included data from the CHAMPION-NMOSD Phase
III trial, which met the primary endpoint with a saf ety profile consistent with the
known profile of the medicine. The CRL requested modifications to enhance the
Ultomiris Risk Evaluation and Mitigation Strategy to further validate patients'
80 Immunoglobulin A neuropathy.
81 Compete Response Letter.
82 Supplemental biologics license application.
===== SIDA 31 =====
31
meningococcal vaccination status or prophylactic administration of antibiotics prior
to treatment. (September 2023)
Presentation:
ASN
SANCTUARY
Phase II
Ultomiris demonstrated c linically meaningful efficacy and proof-of-concept as a
potential treatment for IgAN, based on rapid and su stained proteinuria reduction.
(November 2023)
vemircopan
Event Commentary
Termination
ACH228 -110
Phase II
Trial discontinued due to lack of efficacy. Followi ng an interim analysis,
vemircopan's ability to appropriately control intra vascular haemolysis was not
adequately shown, due to significantly increased rates of breakthrough haemolysis
and high levels of LDH 83 . No new safety findings were observed, and the saf ety
profile of vemircopan has been favourable to date. This decision does not impact
ongoing Phase II trials. (September 2023)
gefurulimab
Event Commentary
Orphan Drug
Designation
US
gefurulimab was granted orphan drug designation by the FDA for the treatment of
patients with gMG. (September 2023)
ALXN2220
Event Commentary
Orphan Drug
Designation
US
ALXN2220 was granted orphan drug designation by the FDA for the treatment of
patients with ATTR-CM 84 . (September 2023)
Interim financial statements
Table 20: Condensed consolidated statement of comprehensive income: 9M 2023
For the nine months ended 30 September 2023 2022
$m $m
Total Revenue 85 33,787 33,144
Product Sales 32,466 32,200
Alliance Revenue 1,004 504
Collaboration Revenue 317 440
Cost of sales (5,960) (9,491)
Gross profit 27,827 23,653
Distribution expense (394) (380)
Research and development expense (7,862) (7,137)
Selling, general and administrative expense (13,845) (13,798)
Other operating income and expense 1,233 325
Operating profit 6,959 2,663
Finance income 236 50
Finance expense (1,181) (986)
Share of after tax losses in associates and joint ventures (12) (4)
Profit before tax 6,002 1,723
Taxation (1,000) 668
Profit for the period 5,002 2,391
Other comprehensive income
Items that will not be reclassified to profit or loss
Remeasurement of the defined benefit pension liability (1) 1,283
83 Lactic dehydrogenase.
84 Transthyretin-mediated amyloid cardiomyopathy.
85 Effective 1 January 2023, the Group has updated the presentation of Total Revenue. See Note 1 for further details of the presentation of
Alliance Revenue.
===== SIDA 32 =====
32
Net gains/(losses) on equity investments measured at fair value through other
comprehensive income
45 (21)
Fair value movements related to own credit risk on bonds designated as fair value
through profit or loss
5 1
Tax on items that will not be reclassified to profit or loss - (291)
49 972
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation (201) (2,493)
Foreign exchange arising on designated liabilities in net investment hedges (63) (321)
Fair value movements on cash flow hedges 62 (214)
Fair value movements on cash flow hedges transferred to profit and loss 28 250
Fair value movements on derivatives designated in net investment hedges 47 33
Costs of hedging (3) (11)
Tax on items that may be reclassified subsequently to profit or loss (7) 95
(137) (2,661)
Other comprehensive loss, net of tax (88) (1,689)
Total comprehensive income for the period 4,914 702
Profit attributable to:
Owners of the Parent 4,995 2,387
Non-controlling interests 7 4
5,002 2,391
Total comprehensive income attributable to:
Owners of the Parent 4,907 701
Non-controlling interests 7 1
4,914 702
Basic earnings per $0.25 Ordinary Share $3.22 $1.54
Diluted earnings per $0.25 Ordinary Share $3.20 $1.53
Weighted average number of Ordinary Shares in issue (millions) 1,549 1,548
Diluted weighted average number of Ordinary Shares in issue (millions) 1,560 1,560
Table 21: Condensed consolidated statement of comprehensive income: Q3 2023
For the quarter ended 30 September 2023 2022
$m $m
Total Revenue 85 11,492 10,982
Product Sales 11,018 10,590
Alliance Revenue 377 214
Collaboration Revenue 97 178
Cost of sales (2,095) (2,982)
Gross profit 9,397 8,000
Distribution expense (129) (126)
Research and development expense (2,584) (2,458)
Selling, general and administrative expense (4,800) (4,277)
Other operating income and expense 70 106
Operating profit 1,954 1,245
Finance income 101 15
Finance expense (392) (339)
Share of after tax (losses)/profits in associates and joint ventures (11) 1
Profit before tax 1,652 922
Taxation (274) 720
Profit for the period 1,378 1,642
Other comprehensive income
Items that will not be reclassified to profit or loss
Remeasurement of the defined benefit pension liability (8) 252
Net gains/(losses) on equity investments measured at fair value through other
comprehensive income
93 (9)
===== SIDA 33 =====
33
Fair value movements related to own credit risk on bonds designated as fair value
through profit or loss
1 (1)
Tax on items that will not be reclassified to profit or loss 5 (16)
91 226
Items that may be reclassified subsequently to profit or loss
Foreign exchange arising on consolidation (306) (1,167)
Foreign exchange arising on designated liabilities in net investment hedges 38 (126)
Fair value movements on cash flow hedges (27) (76)
Fair value movements on cash flow hedges transferred to profit and loss 99 119
Fair value movements on derivatives designated in net investment hedges 7 (1)
Costs of hedging (2) 2
Tax on items that may be reclassified subsequently to profit or loss (19) 49
(210) (1,200)
Other comprehensive loss, net of tax (119) (974)
Total comprehensive income for the period 1,259 668
Profit attributable to:
Owners of the Parent 1,374 1,640
Non-controlling interests 4 2
1,378 1,642
Total comprehensive income attributable to:
Owners of the Parent 1,255 667
Non-controlling interests 4 1
1,259 668
Basic earnings per $0.25 Ordinary Share $0.89 $1.06
Diluted earnings per $0.25 Ordinary Share $0.88 $1.05
Weighted average number of Ordinary Shares in issue (millions) 1,549 1,548
Diluted weighted average number of Ordinary Shares in issue (millions) 1,560 1,559
Table 22: Condensed consolidated statement of financial position
At 30 Sep
2023
At 31 Dec
2022
At 30 Sep
2022
$m $m $m
Assets
Non-current assets
Property, plant and equipment 8,723 8,507 8,352
Right-of-use assets 977 942 875
Goodwill 19,939 19,820 19,707
Intangible assets 37,687 39,307 39,585
Investments in associates and joint ventures 62 76 53
Other investments 1,228 1,066 1,049
Derivative financial instruments 151 74 112
Other receivables 761 835 792
Deferred tax assets 4,057 3,263 3,436
73,585 73,890 73,961
Current assets
Inventories 5,292 4,699 5,078
Trade and other receivables 11,300 10,521 9,336
Other investments 244 239 440
Derivative financial instruments 97 87 105
Intangible assets - - 82
Income tax receivable 697 731 725
Cash and cash equivalents 4,871 6,166 4,458
Assets held for sale - 150 -
22,501 22,593 20,224
Total assets 96,086 96,483 94,185
Liabilities
===== SIDA 34 =====
34
At 30 Sep
2023
At 31 Dec
2022
At 30 Sep
2022
$m $m $m
Current liabilities
Interest-bearing loans and borrowings (5,372) (5,314) (5,408)
Lease liabilities (235) (228) (210)
Trade and other payables (20,542) (19,040) (17,694)
Derivative financial instruments (83) (93) (68)
Provisions (1,193) (722) (377)
Income tax payable (1,163) (896) (1,093)
(28,588) (26,293) (24,850)
Non-current liabilities
Interest-bearing loans and borrowings (22,225) (22,965) (23,013)
Lease liabilities (744) (725) (668)
Derivative financial instruments (75) (164) (290)
Deferred tax liabilities (2,752) (2,944) (3,479)
Retirement benefit obligations (1,048) (1,168) (919)
Provisions (1,189) (896) (930)
Other payables (2,244) (4,270) (4,882)
(30,277) (33,132) (34,181)
Total liabilities (58,865) (59,425) (59,031)
Net assets 37,221 37,058 35,154
Equity
Capital and reserves attributable to equity holders of the
Parent
Share capital 387 387 387
Share premium account 35,166 35,155 35,137
Other reserves 2,078 2,069 2,081
Retained earnings (434) (574) (2,471)
37,197 37,037 35,134
Non-controlling interests 24 21 20
Total equity 37,221 37,058 35,154
Table 23: Condensed consolidated statement of changes in equity
Share
capital
Share
premium
account
Other
reserves
Retained
earnings
Total
attributable
to owners of
the parent
Non-
controlling
interests
Total
equity
$m $m $m $m $m $m $m
At 1 Jan 2022 387 35,126 2,045 1,710 39,268 19 39,287
Profit for the period - - - 2,387 2,387 4 2,391
Other comprehensive loss - - - (1,686) (1,686) (3) (1,689)
Transfer to other reserves - - 36 (36) - - -
Transactions with owners:
Dividends - - - (4,486) (4,486) - (4,486)
Issue of Ordinary Shares - 11 - - 11 - 11
Share-based payments charge
for the period
- - - 471 471 - 471
Settlement of share plan awards - - - (831) (831) - (831)
Net movement - 11 36 (4,181) (4,134) 1 (4,133)
At 30 Sep 2022 387 35,137 2,081 (2,471) 35,134 20 35,154
At 1 Jan 2023 387 35,155 2,069 (574) 37,037 21 37,058
Profit for the period - - - 4,995 4,995 7 5,002
Other comprehensive loss - - - (88) (88) - (88)
Transfer to other reserves - - 9 (9) - - -
Transactions with owners:
Dividends - - - (4,487) (4,487) - (4,487)
===== SIDA 35 =====
35
Dividends paid to non-controlling
interests
- - - - - (4) (4)
Issue of Ordinary Shares - 11 - - 11 - 11
Share-based payments charge
for the period
- - - 429 429 - 429
Settlement of share plan awards - - - (700) (700) - (700)
Net movement - 11 9 140 160 3 163
At 30 Sep 2023 387 35,166 2,078 (434) 37,197 24 37,221
Table 24: Condensed consolidated statement of cash flows
For the nine months ended 30 September 2023 2022
$m $m
Cash flows from operating activities
Profit before tax 6,002 1,723
Finance income and expense 945 936
Share of after tax losses of associates and joint ventures 12 4
Depreciation, amortisation and impairment 4,060 4,000
Decrease in working capital and short-term provisions 150 3,458
Gains on disposal of intangible assets (247) (88)
Fair value movements on contingent consideration arising from business
combinations
202 293
Non-cash and other movements (623) (973)
Cash generated from operations 10,501 9,353
Interest paid (826) (608)
Tax paid (1,710) (1,335)
Net cash inflow from operating activities 7,965 7,410
Cash flows from investing activities
Acquisition of subsidiaries, net of cash acquired (189) -
Payments upon vesting of employee share awards attributable to business
combinations
(84) (297)
Payment of contingent consideration from business combinations (610) (570)
Purchase of property, plant and equipment (836) (719)
Disposal of property, plant and equipment 131 17
Purchase of intangible assets (1,996) (1,298)
Disposal of intangible assets 288 442
Movement in profit-participation liability 190 -
Purchase of non-current asset investments (109) (28)
Disposal of non-current asset investments 32 42
Movement in short-term investments, fixed deposits and other investing
instruments
(12) (321)
Payments to associates and joint ventures - (5)
Interest received 208 26
Net cash outflow from investing activities (2,987) (2,711)
Net cash inflow before financing activities 4,978 4,699
Cash flows from financing activities
Proceeds from issue of share capital 12 11
Issue of loans and borrowings 3,816 -
Repayment of loans and borrowings (4,655) (1,261)
Dividends paid (4,479) (4,364)
Hedge contracts relating to dividend payments (19) (127)
Repayment of obligations under leases (194) (182)
Movement in short-term borrowings 110 378
Payment of Acerta Pharma share purchase liability (867) (920)
Net cash outflow from financing activities (6,276) (6,465)
Net decrease in Cash and cash equivalents in the period (1,298) (1,766)
Cash and cash equivalents at the beginning of the period 5,983 6,038
Exchange rate effects (66) (86)
Cash and cash equivalents at the end of the period 4,619 4,186
===== SIDA 36 =====
36
Cash and cash equivalents consist of:
Cash and cash equivalents 4,871 4,458
Overdrafts (252) (272)
4,619 4,186
Notes to the Interim financial statements
Note 1: Basis of preparation and accounting policies
These unaudited condensed consolidated Interim financial statements for the nine months ended 30 September
2023 have been prepared in accordance with Internat ional Accounting Standard 34, ‘Interim Financial
Reporting' (IAS 34), as issued by the International Accounting Standards Board (IASB), IAS 34 as adopt ed by
the European Union, UK-adopted IAS 34 and the Disclosure Guidance and Transparency Rules sourcebook of
the United Kingdom's Financial Conduct Authority an d with the requirements of the Companies Act 2006 a s
applicable to companies reporting under those standards.
The unaudited Interim financial statements for the nine months ended 30 September 2023 were approved b y
the Board of Directors for publication on 9 November 2023.
This results announcement does not constitute statutory accounts of the Group within the meaning of sections
434(3) and 435(3) of the Companies Act 2006. The annual financial statements of the Group for the year ended
31 December 2022 were prepared in accordance with UK-adopted International Accounting Standards and with
the requirements of the Companies Act 2006. The ann ual financial statements also comply fully with IFR Ss as
issued by the IASB and International Accounting Standards as adopted by the European Union. Except for the
estimation of the interim income tax charge, the In terim financial statements have been prepared apply ing the
accounting policies that were applied in the prepar ation of the Group's published consolidated financi al
statements for the year ended 31 December 2022.
The comparative figures for the financial year ended 31 December 2022 are not the Group's statutory accounts
for that financial year. Those accounts have been reported on by the Group's auditors and have been delivered
to the registrar of companies; their report was (i) unqualified, (ii) did not include a reference to a ny matters to
which the auditors drew attention by way of emphasi s without qualifying their report, and (iii) did no t contain a
statement under section 498(2) or (3) of the Companies Act 2006.
Alliance and Collaboration Revenues
Effective 1 January 2023, the Group has updated the presentation of Total Revenue on the face of the Statement
of Comprehensive Income to include Alliance Revenue as a separate element to Collaboration Revenue.
Alliance Revenue, previously reported within Collab oration Revenue, comprises income related to sales made
by collaboration partners, where AstraZeneca is entitled to a profit share, revenue share or royalties, which are
recurring in nature while the collaboration arrange ment remains in place. Alliance Revenue does not in clude
Product Sales where AstraZeneca is leading commerci alisation in a territory. Collaboration Revenue ari sing
from collaborative arrangements where the Group retains a significant ongoing economic interest and receives
upfront amounts and event-triggered milestones, whi ch arise from the licensing of intellectual propert y, will
continue to be reported as Collaboration Revenue. I n collaboration arrangements either AstraZeneca or the
collaborator acts as principal in sales to the end customer. Where AstraZeneca acts as principal, we r ecord
100% of sales to the end customer within Product Sa les. The revised presentation reflects the increasi ng
importance of income arising from profit share arra ngements where collaboration partners are responsib le for
booking revenues in some or all territories.
The comparative revenue reported in 9M 2023 relatin g to the nine months to 30 September 2022 has been
retrospectively adjusted to reflect the new split of Total Revenue, resulting in Alliance Revenue of $504m being
reported for the nine months to 30 September 2022, however the combined total of Alliance Revenue and
Collaboration Revenue is equal to the previously re ported Collaboration Revenue total for the nine mon ths to
30 September 2022.
Going concern
The Group has considerable financial resources avai lable. As at 30 September 2023, the Group has $11.8 bn
in financial resources (Cash and cash equivalent ba lances of $4.9bn and undrawn committed bank facilit ies of
===== SIDA 37 =====
37
$6.9bn available, of which $2.0bn of the facilities are available until February 2025 and the other $4 .9bn are
available until April 2026, with $5.6bn of borrowin gs due within one year). These facilities contain n o financial
covenants and were undrawn at 30 September 2023.
The Group's revenues are largely derived from sales of medicines covered by patents which provide a relatively
high level of resilience and predictability to cash inflows, although government price interventions i n response
to budgetary constraints are expected to continue t o adversely affect revenues in some of our signific ant
markets. The Group, however, anticipates new revenu e streams from both recently launched medicines and
those in development, and the Group has a wide dive rsity of customers and suppliers across different
geographic areas.
Consequently, the Directors believe that, overall, the Group is well placed to manage its business ris ks
successfully. Accordingly, they continue to adopt t he going concern basis in preparing the Interim fin ancial
statements.
Legal proceedings
The information contained in Note 6 updates the dis closures concerning legal proceedings and contingen t
liabilities in the Group's Annual Report and Form 20-F Information 2022 .
IAS 12 ‘Income Taxes'
On 25 May 2023, the IASB issued an amendment to IAS 12 ‘Income Taxes' to clarify how the effects of th e
global minimum tax framework should be accounted fo r and disclosed effective 1 January 2023. This was
endorsed by the UK Endorsement Board on 19 July 202 3 and has been adopted by the Company for 2023
reporting. The Company is currently assessing the potential impact of these rules upon its financial statements.
The Company has applied the exception to recognisin g and disclosing information about deferred tax ass ets
and liabilities related to Pillar 2 income taxes.
Note 2: Intangible assets
In accordance with IAS 36 ‘Impairment of Assets', reviews for triggers of impairment or impairment reversals at
an individual asset or cash generating unit level were conducted, and impairment tests carried out where triggers
were identified. As a result, total impairment char ges of $376m have been recorded against intangible assets
during the nine months ended 30 September 2023 (9M 2022: $44m net charge). Impairment charges in respect
of medicines in development were $359m (9M 2022: $6 1m net charge) including the $244m impairment of th e
ALXN1840 intangible asset, following decision to discontinue this development programme in Wilson's disease.
Impairment charges in respect of launched medicines were $17m (9M 2022: $nil).
As previously disclosed, on 16 January 2023 AstraZeneca completed the acquisition of Neogene Therapeutics
Inc. (Neogene), a global clinical-stage biotechnolo gy company pioneering the discovery, development an d
manufacturing of next-generation T-cell receptor th erapies (TCR-Ts). The purchase price allocation exe rcise
has completed, with the fair value of total conside ration determined at $267m. Intangible assets of $1 00m and
goodwill of $158m were recognised in the acquisition balance sheet, as well as a cash outflow of $189m net of
cash acquired. Future contingent milestones-based and non-contingent consideration is payable to a maximum
of $120m. Neogene's results have been consolidated into the Group's results from 16 January 2023.
The acquisition of CinCor completed on 24 February 2023, recorded as an asset acquisition, with consideration
and net assets acquired of $1,268m, which included intangible assets acquired of $780m, $424m of cash and
cash equivalents, and $75m of marketable securities . The Condensed consolidated statement of cash flow s
includes a $1,204m payment for the intangible asset s which is presented net of the $424m cash and cash
equivalents acquired within Purchase of intangible assets, whilst the $75m increase in marketable securities is
presented within Movement in short-term investments , fixed deposits and other investing instruments.
Contingent consideration of up to $496m could be pa id on achievement of regulatory milestones, and wil l be
recognised when the associated milestones are triggered.
Note 3: Net debt
The table below provides an analysis of Net Debt and a reconciliation of Net Cash Flow to the movement in Net
Debt. The Group monitors Net Debt as part of its ca pital-management policy as described in Note 28 of the
Annual Report and Form 20-F Information 2022 . Net Debt is a non-GAAP financial measure.
===== SIDA 38 =====
38
Table 25: Net debt
At 1 Jan
2023
Cash
flow
Acquisitions Non-cash
& other
Exchange
movements
At 30 Sep
2023
$m $m $m $m $m $m
Non-current instalments of loans (22,965) (3,826) - 4,592 (26) (22,225)
Non-current instalments of leases (725) (1) (6) (23) 11 (744)
Total long-term debt (23,690) (3,827) (6) 4,569 (15) (22,969)
Current instalments of loans (4,964) 4,655 - (4,587) 39 (4,857)
Current instalments of leases (228) 215 (2) (230) 10 (235)
Bank collateral received (89) (95) - - - (184)
Other short-term borrowings excluding
overdrafts
(78) (15) - - 14 (79)
Overdrafts (183) (69) - - - (252)
Total current debt (5,542) 4,691 (2) (4,817) 63 (5,607)
Gross borrowings (29,232) 864 (8) (248) 48 (28,576)
Net derivative financial instruments (96) 19 - 167 - 90
Net borrowings (29,328) 883 (8) (81) 48 (28,486)
Cash and cash equivalents 6,166 (1,229) - - (66) 4,871
Other investments - current 239 12 - - (7) 244
Cash and investments 6,405 (1,217) - - (73) 5,115
Net debt (22,923) (334) (8) (81) (25) (23,371)
Non-cash movements in the period include fair value adjustments under IFRS 9 Financial Instruments.
The Group has agreements with some bank counterpart ies whereby the parties agree to post cash collater al
on financial derivatives, for the benefit of the other, equivalent to the market valuation of the derivative positions
above a predetermined threshold. The carrying value of such cash collateral held by the Group at 30 September
2023 was $184m (31 December 2022: $89m) and the carrying value of such cash collateral posted by the Group
at 30 September 2023 was $175m (31 December 2022: $162m).
The equivalent GAAP measure to Net debt is ‘liabili ties arising from financing activities', which excl udes the
amounts for cash and overdrafts, other investments and non-financing derivatives shown above and inclu des
the Acerta Pharma share purchase liability of $819m (31 December 2022: $1,646m), which is shown in current
other payables.
Net debt increased by $448m in the nine months to 30 September 2023 to $23,371m. Details of the committed
undrawn bank facilities are disclosed within the going concern section of Note 1.
During the quarter to 30 September 2023, Moody's up graded the Company's solicited long term credit rat ing
from A3 to A2 and its short term rating from P-2 to P-1. Standard and Poor's credit ratings were uncha nged
(long term: A; short term: A-1).
Note 4: Financial Instruments
As detailed in the Group's most recent annual finan cial statements, the principal financial instrument s consist
of derivative financial instruments, other investme nts, trade and other receivables, cash and cash equ ivalents,
trade and other payables, lease liabilities and interest-bearing loans and borrowings.
The Group has certain equity investments that are c ategorised as Level 3 in the fair value hierarchy t hat are
held at $281m at 30 September 2023 (31 December 2022: $186m) and for which fair value gains of $17m have
been recognised in the nine months ended 30 Septemb er 2023 (9M 2022: $50m). In the absence of specific
market data, these unlisted investments are held at fair value based on the cost of investment and adjusting as
necessary for impairments and revaluations on new f unding rounds, which are seen to approximate the fa ir
value. All other fair value gains and/or losses tha t are presented in Net gains/(losses) on equity inv estments
measured at fair value through other comprehensive income in the Condensed consolidated statement of
comprehensive income for the nine months ended 30 S eptember 2023 are Level 1 fair value measurements,
valued based on quoted prices in active markets.
Financial instruments measured at fair value includ e $1,296m of other investments, $3,551m held in mon ey-
market funds, $289m of loans designated at fair val ue through profit or loss and $90m of derivatives a s at 30
September 2023. With the exception of derivatives b eing Level 2 fair valued, certain equity investment s as
===== SIDA 39 =====
39
described above and an equity warrant of $14m categorised as Level 3, the aforementioned balances are Level
1 fair valued. Financial instruments measured at am ortised cost include $175m of cash collateral pledg ed to
counterparties. The total fair value of interest-bearing loans and borrowings at 30 September 2023, which have
a carrying value of $28,576m in the Condensed consolidated statement of financial position, was $26,576m.
As announced in April 2023, the contractual relationship between AstraZeneca and Swedish Orphan Biovitrum
AB (Sobi) relating to future sales of Beyfortus (nirsevimab) in the US has been replaced by a royalty relationship
between Sanofi and Sobi. As a result, a non-current other payable representing AstraZeneca's future obligations
to Sobi was eliminated from AstraZeneca's Statement of Financial Position in the quarter to 30 June 2023, and
AstraZeneca recorded a gain of $712m in Core Other operating income.
Table 26: Financial instruments - contingent consideration
2023 2022
Diabetes
alliance Other Total Total
$m $m $m $m
At 1 January 2,124 98 2,222 2,865
Add itions through business combinations - 60 60 -
Settlements (608) (2) (610) (570)
Disposals - - - (121)
Revaluations 229 (27) 202 293
Discount unwind 93 6 99 126
At 30 September 1,838 135 1,973 2,593
Contingent consideration arising from business comb inations is fair valued using decision-tree analysi s, with
key inputs including the probability of success, co nsideration of potential delays and the expected le vels of
future revenues.
The contingent consideration balance relating to BM S's share of the global diabetes alliance of $1,838 m
(31 December 2022: $2,124m) would increase/decrease by $184m with an increase/decrease in sales of 10%,
as compared with the current estimates.
Note 5: Pensions and other post-retirement benefit obligations
During the nine months ended 30 September 2023, Ast raZeneca Pharmaceuticals PLP terminated its main
defined benefit pension plan. A total of $839m of p ension obligations were discharged, $142m of which was
settled via a cash payment to the participants and the remaining $697m was transferred to an external insurer
via a buy-out. At 30 September 2023, the plan conta ined immaterial residual assets and obligations whi ch are
expected to be discharged by the end of 2023, with minimal impact to the income statement.
Note 6: Legal proceedings and contingent liabilities
AstraZeneca is involved in various legal proceeding s considered typical to its business, including lit igation and
investigations, including Government investigations , relating to product liability, commercial dispute s,
infringement of intellectual property (IP) rights, the validity of certain patents, anti-trust law and sales and
marketing practices. The matters discussed below co nstitute the more significant developments since
publication of the disclosures concerning legal pro ceedings in the Company's Annual Report and Form 20 -F
Information 2022 and the Interim Financial Statements for the six months ended 30 June 2023 (the Disclosures).
As discussed in the Disclosures, the majority of cl aims involve highly complex issues. Often these iss ues are
subject to substantial uncertainties and, therefore , the probability of a loss, if any, being sustaine d and/or an
estimate of the amount of any loss is difficult to ascertain.
Unless specifically identified below, AstraZeneca considers each of the claims to represent a contingent liability
or a contingent asset where the matter is brought by AstraZeneca, and discloses information with respect to the
nature and facts of the cases in accordance with IAS 37.
In cases that have been settled or adjudicated, or where quantifiable fines and penalties have been as sessed
and which are not subject to appeal, or where a loss is probable and we are able to make a reasonable estimate
of the loss, AstraZeneca records the loss absorbed or makes a provision for its best estimate of the e xpected
loss. The position could change over time and the e stimates that the Company made, and upon which the
===== SIDA 40 =====
40
Company have relied in calculating these provisions are inherently imprecise. There can, therefore, be no
assurance that any losses that result from the outc ome of any legal proceedings will not exceed the am ount of
the provisions that have been booked in the accounts. The major factors causing this uncertainty are described
more fully in the Disclosures and herein.
AstraZeneca has full confidence in, and will vigorously defend and enforce, its IP.
Matters disclosed in respect of the third quarter of 2023 and to 9 November 2023
Patent litigation
Legal proceedings brought against AZ considered to be contingent liabilities
Enhertu
US patent proceedings
In October 2020, Seagen Inc. (Seagen) filed a compl aint against Daiichi Sankyo Company, Limited (Daiic hi
Sankyo) in the US District Court for the Eastern Di strict of Texas (District Court) alleging that Enhertu infringes
a Seagen patent. AstraZeneca Pharmaceuticals LP co-commercialises Enhertu with Daiichi Sankyo, Inc. in the
US. After trial in April 2022, the jury found that the patent was infringed and awarded Seagen $41.82m in past
damages. In July 2022, the District Court entered final judgment and declined to enhance damages on the basis
of willfulness. In October 2023, the District Court entered an amended final judgment that requires Da iichi
Sankyo to pay Seagen a royalty of 8% on US sales of Enhertu from April 1, 2022 through November 4, 2024,
in addition to the past damages previously awarded by the Court.
In December 2020 and January 2021, AstraZeneca and Daiichi Sankyo, Inc. filed post-grant review (PGR)
petitions with the US Patent and Trademark Office (USPTO) alleging, inter alia , that the Seagen patent is invalid
for lack of written description and enablement. The USPTO initially declined to institute the PGRs, bu t, in April
2022, the USPTO granted the rehearing requests, ins tituting both PGR petitions. Seagen subsequently
disclaimed all patent claims at issue in one of the PGR proceedings. In July 2022, the USPTO reversed its
institution decision and declined to institute the other PGR petition. AstraZeneca and Daiichi Sankyo requested
reconsideration of the decision not to institute re view of the patent. In February 2023, the USPTO rei nstituted
the PGR proceeding. An oral hearing took place in August 2023. The parties await a decision.
Legal proceedings brought by AZ considered to be contingent assets
Faslodex
Patent proceedings outside the US
In 2021 in Japan, AstraZeneca received notice from the Japan Patent Office (JPO) that Sandoz K.K. (San doz)
and Sun Pharma Japan Ltd. (Sun) were seeking to inv alidate the Faslodex formulation patent. AstraZeneca
defended the challenged patent, and Sun withdrew from the JPO patent challenge. In July 2023, the JPO issued
a final decision upholding various claims of the challenged patent and determining that other patent claims were
invalid. In August 2023, Sandoz appealed the JPO decision to the Japan IP High Court.
Calquence
US patent proceedings
In February 2022, in response to Paragraph IV notic es from multiple ANDA filers, AstraZeneca filed pat ent
infringement lawsuits in the US District Court for the District of Delaware. In its complaint, AstraZeneca alleges
that a generic version of Calquence , if approved and marketed, would infringe patents listed in the US FDA
Orange Book with reference to Calquence that are owned or licensed by AstraZeneca. Trial has been scheduled
for March 2025.
In February 2023, Sandoz Inc. filed a petition for inter partes review with the US Patent and Trademar k Office
(USPTO) of certain Calquence patent claims. AstraZeneca has asserted claims for patent infringement against
Sandoz and other defendants in the US ANDA litigati on. In August 2023, the Patent Trial and Appeal Boa rd
issued a decision denying institution of inter partes review.
Product liability litigation
Legal proceedings brought against AZ for which a provision has been taken
Nexium and Losec /Prilosec
US proceedings
===== SIDA 41 =====
41
In the US, AstraZeneca is defending various lawsuit s brought in federal and state courts involving mul tiple
plaintiffs claiming that they have been diagnosed w ith various injuries following treatment with proto n pump
inhibitors (PPIs), including Nexium and Prilosec . The vast majority of those lawsuits related to al legations of
kidney injuries. In August 2017, the pending federa l court cases were consolidated in a multidistrict litigation
(MDL) proceeding in the US District Court for the District of New Jersey for pre-trial purposes. A bellwether trial
had been scheduled for October 2023, with subsequen t bellwether trials scheduled for November 2023 and
January 2024. In addition to the MDL cases, there were cases filed in Delaware and New Jersey state courts.
In addition, AstraZeneca has been defending lawsuits involving allegations of gastric cancer following treatment
with PPIs. One such claim was filed in the US District Court for the Middle District of Louisiana and is scheduled
to go to trial in April 2024.
In October 2023, AstraZeneca resolved all pending c laims in the MDL, as well as all of the pending cla ims in
Delaware and New Jersey state courts, for $425m, for which a current provision has been taken. A single case
remains pending in the US District Court for the Middle District of Louisiana.
Legal proceedings brought against AZ considered to be contingent liabilities
Farxiga and Xigduo XR
US proceedings
In several jurisdictions in the US, AstraZeneca has been named as a defendant in lawsuits involving pl aintiffs
claiming physical injury, including Fournier's Gang rene and necrotising fasciitis, from treatment with Farxiga
and/or Xigduo XR . A majority of these claims are filed in Delaware state court and remain pending. In September
of 2023, the parties resolved by settlement one case, filed in state court in Minnesota, previously scheduled for
trial in October 2023.
Commercial litigation
Legal proceedings brought against AZ for which a provision has been taken
Alexion Shareholder Litigation (US)
In December 2016, putative securities class action lawsuits were filed in the US District Court for the District of
Connecticut (the District Court) against Alexion an d certain officers and directors, on behalf of purc hasers of
Alexion publicly traded securities during the perio d 30 January 2014 through 26 May 2017. The amended
complaint alleges that defendants engaged in securi ties fraud, including by making misrepresentations and
omissions in its public disclosures concerning Alex ion's Soliris sales practices, management changes, and
related investigations. In August 2021, the Distric t Court issued a decision denying in part Defendant s' motion
to dismiss the matter. The Court granted plaintiffs ' motion for class certification in April 2023. In August 2023,
the parties reached a settlement in principle of th is matter. In September 2023, the court granted pre liminary
approval of the class settlement. The court schedul ed a hearing in December 2023 to rule on final appr oval. A
provision has been recognised in the quarter.
Legal proceedings brought by AZ considered to be contingent assets
US 340B litigations and proceedings
US proceedings
AstraZeneca has been involved in several matters relating to its contract pharmacy recognition policy under the
340B Drug Pricing Program in the US.
In August 2023, AstraZeneca filed a lawsuit against the Attorney General of the State of Louisiana alleging that
the Louisiana's 340B statute, which requires manufa cturers to recognize an unlimited number of contrac t
pharmacies, is preempted on several grounds and violates the Contracts Clause of the U.S. Constitution.
In September 2023, the Arkansas Insurance Departmen t sent AstraZeneca an administrative complaint
concerning compliance with Arkansas's 340B Statute, which requires manufacturers to recognize an unlim ited
number of contract pharmacies. AstraZeneca response is due in November 2023.
Inflation Reduction Act Litigation
US proceedings
In August 2023, AstraZeneca filed a lawsuit in the US District Court for the District of Delaware chal lenging
aspects of the drug price negotiation provisions of the Inflation Reduction Act and the implementing g uidance
and regulations promulgated by the Department of Health and Human Services.
===== SIDA 42 =====
42
Government investigations/proceedings
Legal proceedings brought against AZ considered to be contingent liabilities
340B Qui Tam
US Proceedings
In July 2023, AstraZeneca was served with an unseal ed civil lawsuit brought by a qui tam relator on be half of
the United States, several states, and the District of Columbia in the United States District Court fo r Central
District of California. The complaint alleges that AstraZeneca violated the False Claims Act and State -Law
Counterparts. In September 2023, AstraZeneca filed a motion to dismiss the relator's claims.
Subsequent events
In November, AstraZeneca announced a collaboration and investment agreement with Cellectis, a clinical-stage
biotechnology company, to accelerate the developmen t of next generation therapeutics in areas of high unmet
need, including oncology, immunology and rare disea ses. In Q4 2023, under the terms of the collaborati on
agreement, Cellectis will receive an initial paymen t of $105m from AstraZeneca, which comprises a $25m
upfront cash payment and an $80m equity investment. AstraZeneca expects to treat its investment in Cel lectis
as an associate.
In November, AstraZeneca and Eccogene entered into an exclusive licence agreement for ECC5004, an
investigational oral once-daily GLP-1RA for the treatment of obesity, type-2 diabetes and other cardiometabolic
conditions. Under the terms of the agreement, Astra Zeneca obtained exclusive global rights for develop ment
and commercialisation in all territories except Chi na where Eccogene has the right to co-develop and c o-
commercialise alongside AstraZeneca. Eccogene will receive an initial upfront payment of $185m and up to an
additional $1.825bn in future clinical, regulatory, and commercial milestones and tiered royalties.
Note 7
Table 27: 9M 2023 - Product Sales year-on-year analysis
86
World US Emerging Markets Europe
$m Act % chg CER % chg $m % chg $m Act % chg CER % chg $m Act % chg CER % chg
Oncology 12,692 17 20 5,652 20 2,925 7 15 2,428 19
Tagrisso 4,380 7 10 1,679 14 1,261 4 11 821 6
Imfinzi 3,102 53 56 1,708 55 270 20 31 547 36
Lynparza 2,070 6 9 902 1 409 14 24 543 10
Calquence 1,839 25 26 1,337 12 69 n/m n/m 353 76
Enhertu 178 n/m n/m - - 121 n/m n/m 40 n/m
Orpathys 33 (3) 4 - - 33 (3) 4 - -
Zoladex 699 (3) 5 12 9 521 3 11 98 (2)
Faslodex 217 (16) (10) 9 (38) 113 (6) - 22 (50)
Others 174 (36) (32) 5 (36) 128 (38) (34) 4 (41)
BioPharmaceuticals: CVRM 7,887 14 18 1,972 11 3,507 10 18 1,825 29
Farxiga 4,358 36 40 1,000 34 1,653 35 43 1,356 42
Brilinta 996 (2) - 551 2 224 1 10 203 (5)
Lokelma 300 44 49 156 28 37 n/m n/m 41 98
roxadustat 208 41 51 - - 208 41 51 - -
Andexxa 129 16 19 57 (8) - - - 44 51
Crestor 860 4 11 40 (19) 678 8 15 41 38
Seloken /Toprol-XL 496 (30) (23) - - 482 (30) (24) 8 (19)
Onglyza 180 (12) (8) 44 (26) 99 1 9 25 (17)
Bydureon 123 (40) (40) 101 (43) 2 15 14 20 (30)
Others 237 (16) (13) 23 (13) 124 (19) (13) 87 (10)
BioPharmaceuticals: R&I 4,517 5 8 1,900 (3) 1,315 19 29 847 7
Symbicort 1,842 (4) (1) 589 (18) 600 26 36 408 (8)
Fasenra 1,134 12 13 718 11 48 62 69 262 14
Breztri 478 69 73 263 60 123 73 86 55 n/m
Saphnelo 191 n/m n/m 178 n/m 1 n/m n/m 5 n/m
Tezspire 51 n/m n/m - - - - - 28 n/m
Pulmicort 493 3 10 22 (58) 392 16 24 49 (1)
Bevespi 42 (2) (2) 24 (23) 5 21 32 12 70
Daliresp/Daxas 41 (74) (74) 32 (79) 2 (23) (10) 6 (9)
Others 245 (30) (27) 74 (44) 144 (20) (14) 22 (35)
BioPharmaceuticals: V&I 667 (82) (81) 15 (98) 181 (82) (81) 236 (66)
COVID-19 mAbs 126 (91) (90) - n/m 5 (97) (97) 7 (97)
Vaxzevria 28 (98) (98) - n/m 18 (97) (97) 10 (97)
Beyfortus 52 n/m n/m - - - - - 52 -
Synagis 383 - 6 (1) n/m 158 9 15 109 (12)
86 The table provides an analysis of year-on-year Product Sales, with Actual and CER growth rates reflecting year-on-year growth. Due to
rounding, the sum of a number of dollar values and percentages may not agree to totals.
Financial Statements
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43
FluMist 78 32 28 16 44 - n/m n/m 58 28
Rare Disease 5,793 11 12 3,469 9 487 54 68 1,165 8
Soliris 2,429 (17) (15) 1,313 (22) 338 55 74 530 (15)
Ultomiris 2,141 56 58 1,260 63 47 38 39 495 43
Strensiq 847 23 24 690 26 29 14 16 64 9
Koselugo 246 65 65 144 26 49 n/m n/m 38 n/m
Kanuma 130 17 18 62 11 24 53 55 38 13
Other medicines 910 (27) (22) 104 (7) 580 (5) 3 67 (29)
Nexium 735 (25) (20) 88 (6) 458 5 14 36 (1)
Others 175 (33) (31) 16 (13) 122 (29) (25) 31 (47)
Total Product Sales 32,466 1 4 13,112 3 8,995 1 8 6,568 7
Table 28: Q3 2023 - Product Sales year-on-year analysis 87
World US Emerging Markets Europe
$m Act % chg CER % chg $m % chg $m Act % chg CER % chg $m Act % chg CER % chg
Oncology 4, 389 16 17 1, 986 16 971 4 13 849 22
Tagrisso 1,465 5 6 577 11 409 1 8 281 5
Imfinzi 1,126 53 54 610 48 87 (4) 7 208 54
Lynparza 702 7 8 322 3 131 12 26 178 8
Calquence 654 16 15 468 2 28 n/m n/m 128 63
Enhertu 73 n/m n/m - - 48 n/m n/m 16 n/m
Orpathys 12 6 13 - - 12 6 13 - -
Zoladex 239 - 5 5 29 182 4 11 31 (1)
Faslodex 64 (21) (16) 3 (41) 32 (19) (13) 6 (53)
Others 54 (33) (30) 1 (59) 42 (34) (32) 1 11
BioPharmaceuticals: CVRM 2,683 14 16 690 9 1,161 7 15 657 40
Farxiga 1,554 41 41 366 31 579 41 48 506 54
Brilinta 331 (2) (1) 193 4 64 (16) (4) 68 4
Lokelma 102 30 31 51 15 13 39 48 16 97
roxadustat 74 31 39 - - 74 30 39 - -
Andexxa 40 (3) (5) 20 - - - - 15 32
Crestor 275 (1) 6 14 (10) 219 2 9 9 6
Seloken /Toprol-XL 153 (36) (29) - - 149 (36) (29) 2 (45)
Onglyza 53 (20) (17) 9 (57) 33 - 9 8 (9)
Bydureon 35 (48) (49) 28 (52) 1 97 90 6 (25)
Others 66 (23) (21) 9 15 29 (40) (37) 27 (1)
BioPharmaceuticals: R&I 1,451 2 3 609 (8) 422 14 23 266 9
Symbicort 555 (12) (10) 156 (34) 195 15 24 123 (7)
Fasenra 389 10 10 249 9 19 56 67 86 12
Breztri 171 66 69 98 69 42 51 62 19 n/m
Saphnelo 76 n/m n/m 71 n/m - - - 2 n/m
Tezspire 21 n/m n/m - - - - - 11 n/m
Pulmicort 148 2 7 5 (69) 119 16 24 13 (11)
Bevespi 13 (5) (4) 8 (23) 2 (2) 7 3 77
Daliresp/Daxas 11 (79) (79) 8 (83) - (36) (2) 2 (2)
Others 67 (31) (28) 14 (55) 45 (20) (14) 7 (14)
BioPharmaceuticals: V&I 224 (74) (74) 15 (95) 32 (76) (75) 122 (33)
COVID-19 mAbs - n/m n/m - n/m - n/m n/m - n/m
Vaxzevria - n/m n/m - - - n/m n/m - n/m
Beyfortus 50 n/m n/m - - - - - 50 -
Synagis 99 (5) (1) - - 32 (13) (7) 16 (4)
FluMist 75 28 23 15 41 - - - 56 22
Rare Disease 1,974 13 14 1,179 9 163 49 70 397 15
Soliris 781 (13) (12) 420 (20) 124 47 71 163 (14)
Ultomiris 777 50 49 445 41 17 n/m n/m 184 51
Strensiq 285 20 21 237 23 5 (32) (10) 22 17
Koselugo 87 81 81 54 51 11 51 69 15 n/m
Kanuma 44 21 19 23 27 6 (4) (2) 13 31
Other medicines 297 (27 ) (22 ) 36 (3) 190 (11 ) (4) 19 (32 )
Nexium 244 (22) (17) 29 (6) 153 3 13 11 5
Others 53 (43) (41) 7 10 37 (44) (41) 8 (54)
Total Product Sales 11,018 4 5 4, 515 2 2, 939 3 12 2, 310 18
Table 29: Alliance Revenue
9M 2023 9M 2022
$m $m
Enhertu 741 335
Tezspire 179 42
Vaxzevria: royalties - 67
Other royalty income 59 51
Other Alliance Revenue 25 9
87 The table provides an analysis of year-on-year Product Sales, with Actual and CER growth rates reflecting year-on-year growth. Due to
rounding, the sum of a number of dollar values and percentages may not agree to totals.
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44
Total 1,004 504
Table 30: Collaboration Revenue
9M 2023 9M 2022
$m $m
Lynparza : regulatory milestones - 250
COVID-19 mAbs: licence fees 180 -
Farxiga : sales milestones 28 -
tralokinumab: sales milestones 20 110
Beyfortus : regulatory milestones 71 -
Other Collaboration Revenue 18 80
Total 317 440
Table 31: Other operating income and expense
9M 2023 9M 2022
$m $m
brazikumab licence termination funding 75 104
Divestment of rights to Plendil - 61
Divestment of US rights to Pulmicort Flexhaler 241 -
Update to the contractual relationships for Beyfortus (nirsevimab) 712 -
Other 205 160
Total 1,233 325
Other shareholder information
Financial calendar
Announcement of full year and fourth quarter 2023 results: 8 February 2024
Dividends are normally paid as follows:
First interim: Announced with the half year result s and paid in September
Second interim: Announced with full year results an d paid in March
Contacts
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db@astfinancial.com
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45
Trademarks
Trademarks of the AstraZeneca group of companies ap pear throughout this document in italics. Medical
publications also appear throughout the document in italics. AstraZeneca, the AstraZeneca logotype and the
AstraZeneca symbol are all trademarks of the AstraZ eneca group of companies. Trademarks of companies
other than AstraZeneca that appear in this document include Arimidex and Casodex , owned by AstraZeneca or
Juvisé (depending on geography); Beyfortus , a trademark of Sanofi Pasteur Inc.; Enhertu, a trademark of
Daiichi Sankyo; Losec, owned by AstraZeneca or Cheplapharm (depending upon geography); Seloken , owned
by AstraZeneca or Taiyo Pharma Co., Ltd (depending on geography); Synagis , owned by AstraZeneca or Sobi
aka Swedish Orphan Biovitrum AB (publ). (depending on geography); and Tezspire , a trademark of Amgen, Inc.
Information on or accessible through AstraZeneca's websites, including astrazeneca.com, does not form part
of and is not incorporated into this announcement.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the
discovery, development, and commercialisation of pr escription medicines in Oncology, Rare Disease, and
BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in
Cambridge, UK, AstraZeneca operates in over 100 cou ntries and its innovative medicines are used by millions
of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.
Cautionary statements regarding forward-looking statements
In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform
Act of 1995, AstraZeneca (hereafter ‘the Group') provides the following cautionary statement:
This document contains certain forward-looking stat ements with respect to the operations, performance and
financial condition of the Group, including, among other things, statements about expected revenues, margins,
earnings per share or other financial or other measures. Although the Group believes its expectations are based
on reasonable assumptions, any forward-looking stat ements, by their very nature, involve risks and
uncertainties and may be influenced by factors that could cause actual outcomes and results to be mate rially
different from those predicted. The forward-looking statements reflect knowledge and information avail able at
the date of preparation of this document and the Group undertakes no obligation to update these forward-looking
statements. The Group identifies the forward-lookin g statements by using the words 'anticipates', 'bel ieves',
'expects', 'intends' and similar expressions in such statements. Important factors that could cause actual results
to differ materially from those contained in forward-looking statements, certain of which are beyond the Group's
control, include, among other things:
‒ the risk of failure or delay in delivery of pipeli ne or launch of new medicines
‒ the risk of failure to meet regulatory or ethical requirements for medicine development or approval
‒ the risk of failures or delays in the quality or e xecution of the Group's commercial strategies
‒ the risk of pricing, affordability, access and com petitive pressures
‒ the risk of failure to maintain supply of complian t, quality medicines
‒ the risk of illegal trade in the Group's medicines
‒ the impact of reliance on third-party goods and se rvices
‒ the risk of failure in information technology or c ybersecurity
‒ the risk of failure of critical processes
‒ the risk of failure to collect and manage data in line with legal and regulatory requirements and str ategic
objectives
‒ the risk of failure to attract, develop, engage an d retain a diverse, talented and capable workforce
‒ the risk of failure to meet regulatory or ethical expectations on environmental impact, including cli mate
change
‒ the risk of the safety and efficacy of marketed me dicines being questioned
‒ the risk of adverse outcome of litigation and/or g overnmental investigations
‒ intellectual property-related risks to our product s
‒ the risk of failure to achieve strategic plans or meet targets or expectations
‒ the impact that global and/or geopolitical events may have or continue to have on these risks, on the Group's
ability to continue to mitigate these risks, and on the Group's operations, financial results or finan cial
condition
===== SIDA 46 =====
46
‒ the risk of failure in financial control or the oc currence of fraud
‒ the risk of unexpected deterioration in the Group' s financial position
Nothing in this document, or any related presentation/webcast, should be construed as a profit forecast.
- End of document -